Lausd Complaint

Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 1 of 104 Page ID #:1

1 John W. Howard (SBN 80200) Michelle D. Volk (SBN 217151) 2 Andrew G. Nagurney (SBN 301894) Alyssa P. Malchiodi (SBN 282774) 3 JW Howard/Attorneys, Ltd. 701 B Street, Suite 1725 4 San Diego, California 92101 Tel: 619-234-2842 Fax: 619-234-1716 5 Email: [email protected]

6 7 8 UNITED STATES DISTRICT COURT 9 CENTRAL DISTRICT OF CALIFORNIA 10 WESTERN DIVISION

12 CALIFORNIA EDUCATORS FOR Case No.: 21-cv-02388 LTD

MEDICAL FREEDOM, ARTEMIO 92101 1725 13 QUINTERO, MIGUEL SOTELO,

UITE UITE JANET PHYLLIS BREGMAN, COMPLAINT FOR DECLARATORY

TTORNEYS 14 CEDRIC JOHNSON, MISANON AND INJUNCTIVE RELIEF

ALIFORNIA ALIFORNIA

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TREET (SONI) LLOYD, HEATHER

B IEGO

15 POUNDSTONE, and THERESA D.

OWARD 701

AN AN SANFORD,

H S 16 JW Plaintiffs, 17 v. 18 THE LOS ANGELES UNIFIED 19 SCHOOL DISTRICT, AUSTIN BEUTNER, in his official capacity as DEMAND FOR JURY TRIAL 20 Superintendent of the Los Angeles Unified School District, and LINDA 21 DEL CUETO, in her official capacity as the Director of Human Resources 22 for the Los Angeles Unified School District, 23 Defendants. 24

25 26 Plaintiffs, CALIFORNIA EDUCATORS FOR MEDICAL FREEDOM 27 (“CEMF”), ARTEMIO QUINTERO, MIGUEL SOTELO, JANET PHYLLIS 28 BREGMAN, CEDRIC JOHNSON, MISANON (SONI) LLOYD, HEATHER 1 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 POUNDSTONE, AND THERESA D. SANFORD, by and through their undersigned 2 counsel, sue Defendants, the LOS ANGELES UNIFIED SCHOOL DISTRICT 3 (“LAUSD”), AUSTIN BEUTNER, in his official capacity as the Superintendent of the 4 LAUSD, and LINDA DEL CUETO, in her official capacity as the Director of Human 5 Resources for the LAUSD, and allege as follows: 6 INTRODUCTION 7 1. Plaintiffs are informed and believe and thereon allege that Defendants have 8 implemented a policy mandating that all employees of LAUSD be vaccinated against 9 the virus known as SARS-CoV-2, which causes the corona virus disease known as 10 COVID-19 (together “COVID-19”) by the use of vaccine materials that have not, as 11

yet, been finally approved by the relevant federal agencies, as a condition of their

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12 continuing employment (hereinafter, the “Mandate”).

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1725 13 2. None of the currently available vaccines for COVID-19 (the “COVID

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ALIFORNIA ALIFORNIA Vaccines”) has received final approval from the Food and Drug Administration (the

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15 “FDA”). Rather, each one of the COVID Vaccines is an unapproved product that has

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HOWARD/ been authorized for emergency use under a series of Emergency Use Authorizations

JW 17 (“EUAs”). The statute granting the FDA the power to authorize a medical product for 18 emergency use requires that the person being administered the unapproved product be 19 advised of his or her right to refuse administration of the product. See 21 U.S.C. § 20 360bbb-3(e)(1)(A) (“Section 360bbb-3”). 21 3. For its part, the FDA refers to the COVID Vaccines as “investigational 22 products” – i.e., they remain experimental. In accordance with the governing statute, 23 the FDA requires that patients and caregivers be informed of their right to refuse 24 administration of the product. As well, the FDA has held that the terms and conditions 25 of the EUAs preempt state and local laws that would impose obligations that are 26 inconsistent with those terms and conditions. 27 4. Section 360bbb-3 reflects a fundamental, public policy goal of striking a 28 balance between giving people the option of having access to experimental medical 2 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 products during public emergencies, while also assuring that no one is forced to accept 2 administration of such an experimental medical product. The Mandate effectively 3 usurps that public policy objective and stands in violation of clear federal statutory 4 authority and guidelines. 5 5. Section 360bbb-3 further recognizes the well-settled doctrine that medical 6 experiments, better known in modern parlance as “clinical research”, may not be 7 performed on human subjects without the express, informed consent of the individual 8 receiving treatment. 9 6. This right to avoid the imposition of human experimentation is 10 fundamental, and has its roots in the Nuremberg Code of 1947 and has been ratified by 11

the 1964 Declaration of Helsinki, and further codified in the United States Code of

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12 Federal Regulations. The standard is indeed so universally recognized that it constitutes

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ALIFORNIA ALIFORNIA 7. The Nuremberg principles have been adopted by the California

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15 Legislature, and no person subject to this State’s jurisdiction may be forced to undergo

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JW 17 The Mandate is therefore contrary to the law of this State. 18 8. There is no “pandemic exception” to the law or the Constitution. Plaintiffs 19 ask that the Court intervene to protect their rights before it is too late. 20 PARTIES 21 9. Plaintiff CEMF is a voluntary, unincorporated association of LAUSD 22 employees whose purpose is to advocate for medical choice and bodily autonomy on 23 behalf of its members, vis a vis the Mandate. CEMF’s members are directly affected 24 by the Mandate, and therefore would have standing in their own right to bring this 25 action. As well, the interests at stake in this case are germane to CEMF’s purpose, and 26 neither the claims asserted nor the relief requested requires the individual participation 27 of its members. 28 10. Plaintiff ARTEMIO QUINTERO is a citizen of Los Angeles County, and 3 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 is employed by LAUSD as a Carpenter. 2 11. Plaintiff MIGUEL SOTELO is a citizen of Los Angeles County, and is 3 employed by LAUSD as an Electrician. 4 12. Plaintiff JANET PHYLLIS BREGMAN is a citizen of Los Angeles 5 County, and is employed by LAUSD as a Teacher. 6 13. Plaintiff CEDRIC JOHNSON is a citizen of Los Angeles County, and is 7 employed by LAUSD as a SSS PSA Counselor. 8 14. Plaintiff MIDSANON (SONI) LLOYD is a citizen of Los Angeles County, 9 and is employed by LAUSD as a Teacher. 10 15. Plaintiff HEATHER POUNDSTONE is a citizen of Los Angeles County, 11

and is employed by LAUSD as a Teacher and Librarian.

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12 16. Plaintiff THERESA D. SANFORD is a citizen of Los Angeles County,

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ALIFORNIA ALIFORNIA 17. Allegations regarding “Plaintiffs” hereinbelow shall be deemed to include

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15 the individual Plaintiffs and the members of Plaintiff CEMF.

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HOWARD/ 18. Defendant LAUSD is an independent subdivision of the State of

JW 17 California, and has responsibility for governance of all public schools in the 18 geographical boundaries defined in its governing documents. LAUSD has enacted 19 policies, whether express or implied, that deprive or threaten to deprive Plaintiffs of 20 certain rights, privileges, and immunities under the laws and Constitution of the United 21 States and under the laws and Constitution of the State of California. 22 19. Defendant AUSTIN BEUTNER is the Superintendent of LAUSD, and is 23 sui juris. Mr. Beutner is ultimately charged with, inter alia, enforcing all employment 24 policies of the LAUSD. He is being sued in his official capacity. 25 20. Defendant LINDA DEL CUETO is the Director of Human Resources for 26 LAUSD, and is sui juris. On information and belief, Ms. Del Cueto is charged with 27 developing and enforcing employment policies of LAUSD. She is named as a 28 defendant herein in her official capacity. 4 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 21. Defendants Beutner and Del Cueto have personally undertaken actions 2 under color of law that deprive or imminently threaten to deprive Plaintiffs of certain 3 rights, privileges, and immunities under the laws and Constitution of the United States, 4 and under the laws and Constitution of the State of California. 5 22. Defendants are all state actors unprotected by sovereign immunity for 6 purposes of this action. 7 JURISDICTION AND VENUE 8 23. This Court has jurisdiction to hear this case under 28 U.S.C. § 1331, which 9 confers original jurisdiction on federal district courts to hear suits arising under the laws 10 and Constitution of the United States, as well as under 42 U.S.C. § 1983 in relation to 11

Defendants’ intent to deprive Plaintiffs of certain rights, privileges, and immunities as

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12 detailed herein.

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1725 13 24. This Court has jurisdiction over the claims asserting violations of the laws

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ALIFORNIA ALIFORNIA and Constitution of the State of California through its supplemental jurisdiction under

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15 28 U.S.C. § 1367(a), as those claims are so closely related to the Plaintiffs’ federal

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HOWARD/ question and Section 1983 claims that they form part of the same case or controversy

JW 17 under Article III of the United States Constitution. 18 25. This Court has the authority to award the requested declaratory relief under 19 28 U.S.C. § 2201; the requested injunctive relief under 28 U.S.C. § 1343(a), and 20 attorneys’ fees and costs under 42 U.S.C. § 1988. 21 26. The Central District of California, Western Division is the appropriate 22 venue for this action pursuant to 28 U.S.C. § 1391(b)(1) and (2) because it is the District 23 in which Defendants reside, exercise their authority in their official capacities, and/or 24 have threatened to deprive Plaintiffs of the rights and liberties under the laws and 25 Constitution of the United States, and in addition thereto to violate the laws and 26 Constitution of the State of California, as further alleged herein. It is also the District 27 in which a substantial part of the events giving rise to Plaintiffs’ claims have occurred 28 and continue to occur. 5 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 FACTUAL BACKGROUND 2 The Universal Prohibition on Human Experimentation Without Consent 3 27. Among the horrors that emerged from the rubble of World War II were 4 stories of barbaric medical experiments performed on unwilling victims of Nazi 5 Germany’s concentration camps. 6 28. On August 8, 1945, the prevailing Allies established an International 7 Military Tribunal (the “IMT”). Under the aegis of the IMT, the law authorized the 8 creation of U.S. military tribunals for the trial of “lower-level” war criminals, such as 9 doctors accused of conducting medical experiments without the subjects’ consent.1 10 29. A U.S. military tribunal subsequently found 15 doctors guilty of 11

conducting nonconsensual experiments, which included the testing of drugs for

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12 immunization against malaria, epidemic jaundice, smallpox, and cholera. “In every

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1725 13 single instance appearing in the record,” the tribunal concluded, “subjects were used

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ALIFORNIA ALIFORNIA who did not consent to the experiments. . . .” The tribunal sentenced seven of the

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15 doctors to death, and the remaining eight to life in prison.

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JW 17 Code on Permissible Medical Experiments. Point One of the Nuremberg Code states: 18 “The voluntary consent of the human subject is absolutely essential.” 19 31. This standard has since been repeatedly ratified and adopted around the 20 globe, in laws, treaties, regulations, and ethical guidelines for medical research. For 21 example, in 1964, the World Medical Association adopted the Declaration of Helsinki, 22 which provides that human subjects “must be volunteers and informed participants in 23 the research project.” Declaration of Helsinki at Art. 20. 24 32. Although themselves non-binding, the principles underlying the

25 26 1 Sources for the historical facts set forth herein can be found in Abdullahi v. Pfizer, 27 Inc., 562 F.3d 163 (2d Cir. 2009), which explains in detail the history and reasons why the prohibition against nonconsensual human experimentation should be regarded as a 28 jus cogens norm. 6 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 Declaration of Helsinki and the Nuremberg Code have been incorporated into 2 international conventions, as well as the laws and regulations of countries around the 3 world, including the United States of America. 4 33. The International Covenant on Civil and Political Rights of the United 5 Nations, which went into effect in 1976, provides in Article I that “[a]ll peoples have 6 the right of self determination” and in Article 7 that “no one shall be subjected without 7 his free consent to medical or scientific experimentation.” 8 34. The informed consent principles of the Declaration of Helsinki were also 9 incorporated by a 2001 Directive passed by the European Parliament and the Council 10 of the European Union. 11

35. In addition, 35 members of the Council of Europe have signed the

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12 Convention on Human Rights and Biomedicine, which provides that informed consent

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ALIFORNIA ALIFORNIA 36. In 2005, the General Conference of UNESCO adopted the Universal

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15 Declaration on Bioethics and Human Rights, requiring free and informed consent for

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JW 17 37. On December 1, 2020, the High Court of Justice, Queen’s Bench Division, 18 Administrative Court in the United Kingdom concluded that minors lack the ability to 19 give informed consent to the administration of puberty blockers to treat gender 20 dysphoria because the procedure remains experimental.2 21 38. These principles have been adopted by statutes and regulations in the 22 United States. 23 39. In 1979, the Department of Health, Education and Welfare issued the 24

25 2 26 See Bell v. The Tavistock and Portman NHS Foundation Trust, Case No. CO/60/2020, [2020] EWHC 3274 (Admin) (Engl. & Wales) 27 https://www.judiciary.uk/wp-content/uploads/2020/12/Bell-v-Tavistock- 28 Judgment.pdf.

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1 Belmont Report, which addressed the issue of informed consent in the human 2 experimentation setting. The Report identified respect for self-determination by 3 “autonomous persons” as the first of three “basic ethical principles” which “demands 4 that subjects enter into the research voluntarily and with adequate information.” 5 40. Ultimately, the principles of the Belmont Report, which itself was guided 6 by the Nuremberg Code and the Declaration of Helsinki, were adopted by the FDA in 7 its regulations requiring the informed consent of human subjects for medical research. 8 See 21 C.F.R. § 50.20.3 The Department of Health and Human Services has similarly 9 adopted this standard in its regulations governing grants for medical research. See 45 10 C.F.R. § 46.116. The United States clearly regards itself as bound by the provisions of 11

the Nuremberg Code and the Declaration of Helsinki.

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12 41. The Nuremberg principles have also been adopted by this State. See Cal.

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ALIFORNIA ALIFORNIA subjects).

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15 42. For these and other reasons, the prohibition against nonconsensual human

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HOWARD/ experimentation must be regarded not only as established by U.S. law and regulations,

JW 17 but also as so broadly recognized by all nations as to constitute a jus cogens norm under 18 international law.

19 20 3 The exceptions to this standard are extremely narrow, and require certification 21 by a researcher and an independent physician that, for example, “[t]he human subject is confronted with a life-threatening situation necessitating the use of the test article”; 22 informed consent cannot be obtained from the subject; time does not permit obtaining 23 informed consent from the subject’s legal representative; and “there is available no alternative method of approved or generally recognized therapy that provides an equal 24 or greater likelihood of saving the life of the subject.” 21 C.F.R. § 50.23. See also 21 25 C.F.R. § 50.24 (providing a similarly narrow exception to informed consent requirements for emergency research). 26

27 4 California is not the only state to encode the Nuremberg principles. See, e.g., Pub NY Health Ch. 45, Art. 24-a (mandating informed consent in human research); 28 VA Code Ann. § 32.1-162.18 (same). 8 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 Operation Warp Speed 2 43. On January 30, 2020, the World Health Organization (“WHO”) declared a 3 “public health emergency of international concern over the global outbreak” of COVID- 4 19. Among other recommendations, the WHO called for accelerated development of 5 “vaccines, therapeutics and diagnostics.” 6 44. The following day, U.S. Health and Human Services (“HHS”) Secretary 7 Alex Azar declared a national Public Health Emergency (“PHE”), retroactive to January 8 27, 2020, “to aid the nation’s healthcare community in responding” to COVID-19. By 9 then, HHS was already collaborating with the pharmaceutical industry regarding the 10 development of vaccines. 11

45. In April 2020, the national Administration announced Operation Warp

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12 Speed (“OWS”) – a public/private partnership to develop and distribute a vaccine for

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ALIFORNIA ALIFORNIA 46. The process for developing a vaccine normally takes place in several

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15 phases, over a period of years.

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HOWARD/ 47. The general stages of the development cycle for a vaccine are:

JW 17 a. Exploratory stage; 18 b. Pre-clinical stage (animal testing); 19 c. Clinical development (human trials – see below); 20 d. Regulatory review and approval; 21 e. Manufacturing; and 22 f. Quality control.5 23 48. The third stage, clinical development, is itself a three-phase process: 24 a. During Phase I, small groups of people receive the trial vaccine. 25 b. In Phase II, the clinical study is expanded and vaccine is given to people 26 who have characteristics (such as age and physical health) similar to

27 28 5 https://www.cdc.gov/vaccines/basics/test-approve.html. 9 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 those for whom the new vaccine is intended. 2 c. In Phase III, the vaccine is given to thousands of people and tested for 3 efficacy and safety. 4 49. Phase III itself normally occurs over a course of years. That is because it 5 can take years for the side effects of a new vaccine to manifest themselves. 6 50. Phase III must be followed by a period of regulatory review and approval. 7 During this stage, data and outcomes are reviewed by peers and by the FDA. 8 51. Finally, the manufacturer must demonstrate that the vaccine can be 9 manufactured under conditions that assure adequate quality control. 10 52. The timeline set by OWS telescoped what would normally take years of 11

research into a matter of months.

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12 53. Commercial vaccine manufacturers and other entities proceeded with

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ALIFORNIA ALIFORNIA RNA, DNA, protein, and viral vectored vaccines.

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15 54. Two potential vaccines emerged early on as likely candidates: one

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HOWARD/ developed by Moderna (the “Moderna Vaccine”), the other by Pfizer (the “Pfizer

JW 17 Vaccine”), with both announcing Phase III trial results in November 2020. 18 55. In early 2021, Janssen Biotech, Inc. submitted Phase III trial results for its 19 adenovirus vector vaccine (the “Janssen Vaccine”). 20 The EUAs 21 56. Congress enacted Title 21, Section 360bbb-3 of the Federal Food, Drug, 22 and Cosmetic Act (the “FFDCA”) to vest the Secretary of Health and Human Services 23 with permissive authority to “authorize the introduction into interstate commerce, 24 during the effective period of a declaration [of emergency], of a drug, device, or 25 biological product intended for use in an actual or potential emergency. . . .” 21 U.S.C. 26 § 360bbb-3(a)(1). 27 57. The statute provides for the authorization of both unapproved products and 28 unapproved uses of an approved product. See 21 U.S.C. § 360bbb-3(a)(2). The 10 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 Vaccines fall under the former category, as they have not been previously approved for 2 any use, nor have they been approved to date. 3 58. Section 360bbb-3 mandates the following conditions for authorization of 4 an unapproved product: 5 . . . [T]he Secretary, to the extent practicable given the 6 applicable circumstances described in subsection (b)(1), 7 shall, for a person who carries out any activity for which the 8 authorization is issued, establish such conditions on an 9 authorization under this section as the Secretary finds 10 necessary or appropriate to protect the public health, 11

including the following:

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ALIFORNIA ALIFORNIA individuals to whom the product is administered are

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15 informed—

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JW 17 . . . (III) of the option to accept or refuse administration of 18 the product. . . . 19 20 21 U.S.C. § 360bbb-3(e)(1)(A)(ii) (emphasis added). 21 59. Pfizer and Moderna applied for EUAs under Section 360bbb-3 in 22 November-December 2020. Janssen applied for an EUA in early 2021. 23 60. On December 11, 2020, the FDA granted an EUA for the Pfizer Vaccine. 24 An updated version of the EUA Letter to Pfizer is attached hereto as Exhibit “A”. 25 61. The FDA granted an EUA for the Moderna Vaccine on December 18, 26 2020. The EUA Letter to Moderna is attached hereto as Exhibit “B”. 27 62. The FDA granted an EUA for the Janssen Vaccine on February 27, 2021. 28 The EUA Letter to Janssen is attached hereto as Exhibit “C”. 11 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 63. Each of the EUA Letters provides details regarding the reasoning for the 2 EUAs, and dictating strict conditions for, among other things, administering the 3 Vaccines. 4 64. Under “Conditions of Authorization,” each of the EUA letters directs that 5 the manufacturers: 6 and authorized distributor(s) will ensure that the authorized [] 7 COVID-19 Vaccine is distributed, as directed by the U.S. 8 government, including CDC and/or other designee, and the 9 authorized labeling (i.e., Fact Sheets) will be made available 10 to vaccination providers, recipients, and caregivers consistent 11

with the terms of this letter.

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12 See, e.g., Ex. “C” at 5, ¶A.

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1725 13 65. Each EUA Letter is accompanied by a Fact Sheet for Health Care

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ALIFORNIA ALIFORNIA Providers and a Fact Sheet for Patients and Caregivers. The Fact Sheets to Providers

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15 mandate, among other things, that a provider must communicate, to the recipient or the

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JW 17 prior to administering the vaccine, including information that “the recipient or their 18 caregiver has the option to accept or refuse” the vaccine. See Pfizer Fact Sheet for 19 Health Care Providers, attached as Exhibit “D” (emphasis added). 20 66. The Fact Sheets for Recipients and Caregivers likewise contain the 21 following advice: 22 WHAT IF I DECIDE NOT TO GET THE [] COVID-19 23 VACCINE? 24 25 It is your choice to receive or not receive the [] COVID-19 26 Vaccine. Should you decide not to receive it, it will not 27 change your standard medical care. 28 12 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 See Moderna Fact Sheet for Recipients and Caregivers, attached as Exhibit “E” 2 (emphasis added). 3 67. Consistent with its mandate under Section 360bbb-3, the FDA continues 4 to refer to the Vaccines as “unapproved” or “investigational” products. See, e.g., Ex. 5 “D” at 8 (referring to Pfizer Vaccine as an “unapproved product”) (emphasis added); 6 Ex. “B” at 1 (noting that the Moderna Vaccine “is an investigational vaccine not 7 licensed for any indication”) (emphasis added). 8 68. In other words, as a legal matter and as a matter of FDA policy and 9 guidance, the Vaccines remain experimental.6 10 69. Separate and apart from the requirements of Section 360bbb-3 and the 11

FDA’s guidance thereunder, Plaintiffs have a reasonable apprehension that the

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12 technology underlying the Moderna Vaccine (the vaccine being acquired by LAUSD)

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ALIFORNIA ALIFORNIA 70. As noted above, the Moderna Vaccine uses messenger RNA (“mRNA”).

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15 Before last year, no mRNA-based vaccine had ever made it to human trials, because

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JW 17 dangerous immune reactions, even resulting in death, in animal subjects, making it too 18 dangerous to test on humans. Even if that problem has been solved, given the severely 19 telescoped timeline for development, no one knows at this time what will be the long- 20 term effects of mRNA vaccine technology. It is, by definition, experimental medicine. 21 The Mandate 22 71. On or about March 16, 2020, LAUSD closed all schools in Los Angeles 23 County to in-person instruction. 24 72. Since that time, LAUSD has struggled to come up with a plan for

25 26 6 Only one vaccine, against inhaled anthrax, has ever previously been approved for 27 emergency use. A district court found that it was an investigational drug and enjoined its forced administration to military servicemembers without their informed consent. 28 See Doe v. Rumsfeld, 297 F. Supp. 2d 119 (D.D.C. 2003). 13 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 reopening for in-classroom instruction.7 2 73. In or about February 2021, Plaintiffs began to receive communications 3 from Defendant Beutner, and other representatives of LAUSD, instructing them to 4 make appointments to get vaccinated. None of these communications have included 5 the Fact Sheet information required by the FDA to be disseminated to recipients under 6 the EUAs. 7 74. On March 4, 2021, Defendant Del Cueto distributed an interoffice 8 memorandum to the local district superintendents regarding “Human Resources 9 COVID-19 Employee Vaccination Information and Resources,” a true and correct copy 10 of which is attached hereto as Exhibit “F”. 11

75. The memorandum includes as “ATTACHMENT 1” Defendants’

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12 “VACCINATION GUIDANCE FOR EMPLOYEES” (the “Guidance”). The Guidance

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ALIFORNIA ALIFORNIA a. The Moderna vaccine is currently being administered by Los Angeles

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15 Unified nurses and other licensed healthcare professionals to Los

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JW 17 b. You will schedule your appointment . . . . 18 c. You will provide proof of vaccination via the DailyPass for time 19 reporting purposes. 20 Ex. “F” (emphasis added). 21 76. ATTACHMENT 2 provides guidance for supervisors, and contains 22 essentially the same language. 23 77. The Guidance clearly indicates that vaccination is mandatory. 24

25 7 This has been despite growing evidence that large public schools have, since the 26 fall semester of 2020, reopened safely for in-classroom instruction, with positivity rates 27 for COVID-19 well below those for their surrounding communities. See https://www.cnn.com/2021/01/11/us/miami-dade-schools-open-coronavirus- 28 wellness/index.html. 14 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 78. As well, Defendant Del Cueto made a verbal statement in the presence of 2 Plaintiff Quintero to the effect that the vaccine is mandatory, and that any refusal by an 3 employee to get vaccinated will trigger disciplinary action. 4 79. A representative of Teamsters Local 572 informed employees of LAUSD’s 5 Operations department via email of the results of a “Q&A” session with representatives 6 of LAUSD. See Exhibit “G”, attached hereto. The email states that, in response to a 7 question as to whether vaccinations will be mandatory, LAUSD representatives 8 answered: “All District employees will be required to be vaccinated. No exceptions 9 have been made. . . .” (emphasis in original). Id. 10 80. The foregoing communications, as well as other statements made to 11

Plaintiffs by supervisors and union representatives, all indicate that Defendants have

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12 formed an express or de facto policy, referred to herein as the Mandate, that requires

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ALIFORNIA ALIFORNIA disciplinary action.

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15 81. Plaintiffs have further been informed that any refusal to be vaccinated by

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JW 17 employment. 18 82. LAUSD is a political subdivision of the State of California with a 19 governing board publicly elected by residents of Los Angeles County and Defendants 20 Beutner and Del Cueto are employees of LAUSD. The Mandate therefore constitutes 21 “state action” taken “under color of law.” 22 PLAINTIFFS’ CONCERNS AND STANDING TO SEEK DECLARATORY 23 RELIEF 24 83. Plaintiffs are all employees of LAUSD who are directly affected by the 25 Mandate. 26 84. The conditions of the EUAs prohibit any person from administering the 27 Vaccines without the consent of the patient, as particularly described hereinabove and 28 governmental agencies from requiring non-consensual administration of same. 15 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 85. More broadly, Plaintiffs have a universally recognized, fundamental right 2 to be free from human medical experimentation, a right that is protected by recognized 3 international legal standards, international treaties to which the United States is a 4 member, the laws and regulations of the United States, and the Due Process Clause of 5 the Fourteenth Amendment. 6 86. Plaintiffs do not consent to being administered the COVID Vaccines. 7 87. Because Defendants have indicated that administration of the COVID 8 Vaccine will be a condition of their ongoing employment, Plaintiffs are uncertain of 9 their rights, and seek declaratory relief in order to have clarity as to their rights. A real 10 and concrete controversy exists between Plaintiffs and Defendants in that Defendants 11

contend that they have the right, power and authority to require involuntary vaccination

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12 as a condition of continuing employment at a public, governmental agency and

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15 of the State of California to refuse vaccination without discipline or impairment of their

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JW 17 88. All conditions precedent to this action have been performed, excused, 18 and/or waived. 19 FIRST CLAIM 20 (All Defendants) 21 FEDERAL PREEMPTION 22 89. Plaintiffs reallege and incorporate by reference their allegations in 23 Paragraphs 1 – 88, as if fully alleged herein, and further allege: 24 90. Federal laws and regulations governing the administration of medical 25 products such as vaccines, including Section 360bbb-3 and the FDA’s regulations, 26 protocols, and guidance thereunder, fully occupy the field and explicitly and completely 27 preempt any and all contrary or inconsistent laws of the States and/or local 28 governments. 16 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 91. The clear intent of Section 360bbb-3 and of the FDA’s guidance and 2 regulations implementing the statute is to allow, in the course of a medical crisis, 3 voluntary access to unapproved – i.e., experimental – medical products. It was plainly 4 not the intent of Congress to shortcut the formal approval process for medical products 5 such as vaccines. 6 92. By mandating that all employees of LAUSD be administered the COVID 7 Vaccine, Defendants usurp and frustrate the intent of Congress, and the mission of the 8 FDA in carrying out that intent. 9 93. Because the COVID Vaccines are investigational products, authorized – 10 not approved – for use under an Emergency Use Authorization, the laws and regulations 11

of the United States prohibit their administration to any person who does not consent.

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12 94. Plaintiffs do not consent to being administered the COVID Vaccines.

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15 96. As well, Title 21, Part 50 of the Code of Federal Regulations governs the

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JW 17 the U.S. Food and Drug Administration. 18 97. 21 C.F.R. § 50.20 provides that, “[e]xcept as provided in §§ 19 50.23 and 50.24, no investigator may involve a human being as a subject in research 20 covered by these regulations unless the investigator has obtained the legally effective 21 informed consent of the subject or the subject's legally authorized representative.” 22 98. None of the exemptions provided in sections 50.23 and 50.24 would apply 23 to Plaintiffs. 24 99. Accordingly, the Mandate at issue violates federal regulations governing 25 the administration of experimental medicine, and is thus preempted. 26 100. A real and immediate controversy exists between the parties requiring the 27 intervention of this Court by way of declaratory relief to determine the respective rights 28 and powers of the respective parties. In addition, Plaintiffs have no adequate remedy at 17 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 law available against Defendants for the injuries and the irreparable harm they will 2 imminently suffer as a direct result of the Mandate. 3 SECOND CLAIM 4 (All Defendants) 5 SUBSTANTIVE DUE PROCESS – MEDICAL EXPERIMENTATION 6 42 U.S.C. §1983 7 101. Plaintiffs reallege and incorporate by reference their allegations in 8 Paragraphs 1 – 88, as if fully alleged herein, and further allege: 9 102. As set forth above, the COVID Vaccines are experimental. 10 103. Plaintiffs have a protected liberty interest, secured by the Due Process 11

Clause of the United States Constitution, international protocols and international

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12 treaties adopted by and entered into by the United States of America, and by the laws

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15 nations, which prohibits human medical experimentation without informed consent.

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HOWARD/ 105. Plaintiffs do not consent to being administered the COVID Vaccines.

JW 17 106. Defendants have instituted a District-wide Mandate requiring that all 18 employees of LAUSD be vaccinated against COVID-19. 19 107. The Mandate constitutes the official or de facto policy of LAUSD, such 20 that LAUSD is a “person” for purposes of Section 1983. 21 108. Defendants are state actors, and have instituted or imminently intend to 22 institute the Mandate under color of law. 23 109. The forcible administration of the COVID Vaccines, on pain of 24 termination from employment, would deprive Plaintiffs of their substantive due process 25 rights and constitute a violation of their property rights under Skelly v. State Personnel 26 Board (1974) 15 Cal.3rd 194. 27 110. The harm to Plaintiffs cannot be adequately redressed in the event that the 28 Mandate is carried out. 18 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 THIRD CLAIM 2 (All Defendants) 3 VIOLATION OF CALIFORNIA’S 4 PROTECTION OF HUMAN SUBJECTS IN MEDICAL EXPERIMENTATION 5 ACT, CAL. HEALTH & SAFETY CODE § 24170, et. seq. 6 111. Plaintiffs reallege and incorporate by reference their allegations in 7 Paragraphs 1 – 88, as if fully alleged herein, and further allege: 8 112. Plaintiffs invoke the Court’s supplemental jurisdiction to claim that the 9 Mandate violates the law of this State governing human medical experimentation. 10 113. The Protection of Human Subjects in Medical Experimentation Act (the 11

“Act”) adopts the Belmont principles by prohibiting medical experimentation on human

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12 subjects without their informed consent. Cal. Health & Saf. Code § 24170, et. seq.

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ALIFORNIA ALIFORNIA 115. The Mandate is therefore facially void, as a matter of law.

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15 116. Even if the Mandate is not void, Plaintiffs do not consent to being

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JW 17 117. Plaintiffs reserve their rights to seek damages and other relief as the Court 18 may deem just, pursuant to Section 24176 of the Act. 19 PRAYER FOR RELIEF 20 WHEREFORE, Plaintiffs pray for judgment in its favor and against 21 Defendants, and each of them, as follows: 22 FIRST CLAIM 23 1. For declaratory judgment that Defendants’ Mandate requiring administration of 24 the COVID Vaccines to each of them violates and is preempted by the laws and 25 regulations of the United States governing the administration of investigational 26 medical products, for an injunction prohibiting enforcement of the Mandate; and 27 2. For attorneys’ fees and costs pursuant to 42 U.S.C. § 1988. 28 / / / 19 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 SECOND CLAIM 2 1. For declaratory judgment that Defendants’ Mandate requiring administration of 3 the COVID Vaccines to each of them violates their rights to substantive due 4 process and/or their liberty and property interests under the Fourteenth 5 Amendment to the Constitution of the United States and the laws and 6 Constitution of the State of California, that Defendants be enjoined from 7 administering any COVID Vaccines to any Plaintiff without that Plaintiff’s 8 express informed consent; and 9 2. For attorneys’ fees and costs as provided in 42 U.S.C. § 1988. 10 THIRD CLAIM 11

1. For declaratory judgment that Defendants’ Mandate Violates California Health

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12 and Safety Code §§ 24170, et. seq., and that the Court enjoin Defendants from

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ALIFORNIA ALIFORNIA ALL CLAIMS

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15 1. For judgment in favor of Plaintiffs;

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HOWARD/ 2. For costs of suit herein; and

JW 17 3. For such other and further relief as the Court deems just and proper. 18 19 Dated: March 17, 2021 JW HOWARD/ATTORNEYS 20 21 /s/ John W. Howard John W. Howard 22 Attorney for Plaintiffs

20 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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1 DEMAND FOR JURY TRIAL 2 Plaintiffs demand a right to a jury trial for all matters so triable. 3 4 Dated: March 17, 2021 JW HOWARD/ATTORNEYS 5 6 /s/ John W. Howard John W. Howard 7 Attorney for Plaintiffs

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JW 17 18 19 20 21 22

23 24 25 26 27 28

21 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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EXHIBIT “A”

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February 25, 2021

Pfizer Inc. Attention: Ms. Elisa Harkins 500 Arcola Road Collegeville, PA 19426

Dear Ms. Harkins:

On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes Coronavirus Disease 2019 (COVID-19).1 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act) (21 U.S.C. 360bbb-3), subject to terms of any authorization issued under that section.2

On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 for individuals 16 years of age and older pursuant to Section 564 of the Act. On December 23, 2020, FDA reissued the December 11, 2020 letter to, among other revisions, remove reference to the number of doses per vial after dilution.3

On February 25, 2021, again having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the December 23, 2020, letter in its entirety with revisions incorporated to allow flexibility on the date of submission of monthly periodic safety reports and to revise the requirements for reporting of vaccine administration errors by Pfizer Inc. The Fact Sheet for Health Care Providers

2 U.S. Department of Health and Human Services, Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3, 85 FR 18250 (April 1, 2020).

3 In the December 23, 2020 revision, in addition to removal of the reference to the number of doses per vial after dilution from the letter of authorization, FDA clarified the instructions for vaccination provider reporting to VAERS, and made other technical corrections. FDA also revised the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) to clarify the number of doses of vaccine per vial after dilution and the instructions for reporting to VAERS. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and the Fact Sheet for Recipients and Caregivers were revised to include additional information on safety monitoring and to clarify information about the availability of other COVID-19 vaccines.

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Administering Vaccine (Vaccination Providers) is being revised to provide an update to the storage and transportation temperature for frozen vials, direct the provider to the correct CDC website for information on monitoring vaccine recipients for the occurrence of immediate adverse reactions, to include data from a developmental toxicity study, and add adverse reactions that have been identified during post authorization use. The Fact Sheet for Recipients and Caregivers is being revised to add adverse reactions that have been identified during post authorization use.

Pfizer-BioNTech COVID‑19 Vaccine is for use for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The vaccine contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid particles. It is an investigational vaccine not licensed for any indication.

FDA reviewed safety and efficacy data from an ongoing phase 1/2/3 trial in approximately 44,000 participants randomized 1:1 to receive Pfizer-BioNTech COVID‑19 Vaccine or saline control. The trial has enrolled participants 12 years of age and older. FDA’s review has considered the safety and effectiveness data as they relate to the request for emergency use authorization in individuals 16 years of age and older. FDA’s review of the available safety data from 37,586 of the participants 16 years of age and older, who were followed for a median of two months after receiving the second dose, did not identify specific safety concerns that would preclude issuance of an EUA. FDA’s analysis of the available efficacy data from 36,523 participants 12 years of age and older without evidence of SARS-CoV-2 infection prior to 7 days after dose 2 confirm the vaccine was 95% effective (95% credible interval 90.3, 97.6) in preventing COVID-19 occurring at least 7 days after the second dose (with 8 COVID-19 cases in the vaccine group compared to 162 COVID-19 cases in the placebo group). Based on these data, and review of manufacturing information regarding product quality and consistency, it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective. Additionally, it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine outweigh the known and potential risks of the vaccine, for the prevention of COVID-19 in individuals 16 years of age and older. Finally, on December 10, 2020, the Vaccines and Related Biological Products Advisory Committee voted in agreement with this conclusion.

Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization.

I. Criteria for Issuance of Authorization

I have concluded that the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:

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1. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;

2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and

3. There is no adequate, approved, and available alternative to the emergency use of Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19.4

II. Scope of Authorization

I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited as follows:

• Pfizer Inc. will supply Pfizer-BioNTech COVID‑19 Vaccine either directly or through authorized distributor(s)5, to emergency response stakeholders6 as directed by the U.S. government, including the Centers for Disease Control and Prevention (CDC) and/or other designee, for use consistent with the terms and conditions of this EUA; • The Pfizer-BioNTech COVID‑19 Vaccine covered by this authorization will be administered by vaccination providers7 and used only to prevent COVID-19 in individuals ages 16 and older; and

4 No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.

5 “Authorized Distributor(s)” are identified by Pfizer Inc. or, if applicable, by a U.S. government entity, such as the Centers for Disease Control and Prevention (CDC) and/or other designee, as an entity or entities allowed to distribute authorized Pfizer-BioNTech COVID‑19 Vaccine.

6 For purposes of this letter, “emergency response stakeholder” refers to a public health agency and its delegates that have legal responsibility and authority for responding to an incident, based on political or geographical boundary lines (e.g., city, county, tribal, territorial, State, or Federal), or functional (e.g., law enforcement or public health range) or sphere of authority to administer, deliver, or distribute vaccine in an emergency situation. In some cases (e.g., depending on a state or local jurisdiction’s COVID-19 vaccination response organization and plans), there might be overlapping roles and responsibilities among “emergency response stakeholders” and “vaccination providers” (e.g., if a local health department is administering COVID-19 vaccines; if a pharmacy is acting in an official capacity under the authority of the state health department to administer COVID-19 vaccines). In such cases, it is expected that the conditions of authorization that apply to emergency response stakeholders and vaccination providers will all be met.

7 For purposes of this letter, “vaccination provider” refers to the facility, organization, or healthcare provider licensed or otherwise authorized by the emergency response stakeholder (e.g., non-physician healthcare professionals, such as nurses and pharmacists pursuant to state law under a standing order issued by the state health officer) to administer or provide vaccination services in accordance with the applicable emergency response stakeholder’s official COVID-19 vaccination and emergency response plan(s) and who is enrolled in the CDC COVID-19 Vaccination Program. For purposes of this letter, “healthcare provider” also refers to a person authorized by the U.S. Department of Health and Human Services (e.g., under the PREP Act Declaration for Medical

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• Pfizer-BioNTech COVID‑19 Vaccine may be administered by a vaccination provider without an individual prescription for each vaccine recipient.

Product Description

The Pfizer-BioNTech COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. The Pfizer-BioNTech COVID-19 Vaccine does not contain a preservative.

Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine contains 30 mcg of a nucleoside- modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2. Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients: lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3- phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection) contributes an additional 2.16 mg sodium chloride per dose.

The dosing regimen is two doses of 0.3 mL each, 3 weeks apart.

The manufacture of the authorized Pfizer-BioNTech COVID‑19 Vaccine is limited to those facilities identified and agreed upon in Pfizer’s request for authorization.

The Pfizer-BioNTech COVID-19 Vaccine vial label and carton labels are clearly marked for “Emergency Use Authorization.” The Pfizer-BioNTech COVID‑19 Vaccine is authorized to be distributed, stored, further redistributed, and administered by emergency response stakeholders when packaged in the authorized manufacturer packaging (i.e., vials and cartons), despite the fact that the vial and carton labels may not contain information that otherwise would be required under the FD&C Act.

Pfizer-BioNTech COVID‑19 Vaccine is authorized for emergency use with the following product-specific information required to be made available to vaccination providers and recipients, respectively (referred to as “authorized labeling”):

• Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID‑19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19)

Countermeasures against COVID-19) to administer FDA-authorized COVID-19 vaccine (e.g., qualified pharmacy technicians and State-authorized pharmacy interns acting under the supervision of a qualified pharmacist). See, e.g., HHS. Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of the Declaration. 85 FR 79190 (December 9, 2020).

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• Fact Sheet for Recipients and Caregivers: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID‑19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) in Individuals 16 Years of Age and Older

I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine, when used to prevent COVID-19 and used in accordance with this Scope of Authorization (Section II), outweigh its known and potential risks.

I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19 when used in accordance with this Scope of Authorization (Section II), pursuant to Section 564(c)(2)(A) of the Act.

Having reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section I above, I have concluded that Pfizer-BioNTech COVID‑19 Vaccine (as described in this Scope of Authorization (Section II)) meets the criteria set forth in Section 564(c) of the Act concerning safety and potential effectiveness.

The emergency use of Pfizer-BioNTech COVID‑19 Vaccine under this EUA must be consistent with, and may not exceed, the terms of the Authorization, including the Scope of Authorization (Section II) and the Conditions of Authorization (Section III). Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination under Section 564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under Section 564(b)(1), Pfizer-BioNTech COVID‑19 Vaccine is authorized to prevent COVID-19 in individuals 16 years of age and older as described in the Scope of Authorization (Section II) under this EUA, despite the fact that it does not meet certain requirements otherwise required by applicable federal law.

III. Conditions of Authorization

Pursuant to Section 564 of the Act, I am establishing the following conditions on this authorization:

Pfizer Inc. and Authorized Distributor(s)

A. Pfizer Inc. and authorized distributor(s) will ensure that the authorized Pfizer- BioNTech COVID‑19 Vaccine is distributed, as directed by the U.S. government, including CDC and/or other designee, and the authorized labeling (i.e., Fact Sheets) will be made available to vaccination providers, recipients, and caregivers consistent with the terms of this letter.

B. Pfizer Inc. and authorized distributor(s) will ensure that appropriate storage and cold chain is maintained until delivered to emergency response stakeholders’ receipt sites.

C. Pfizer Inc. will ensure that the terms of this EUA are made available to all relevant stakeholders (e.g., emergency response stakeholders, authorized distributors, and

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vaccination providers) involved in distributing or receiving authorized Pfizer- BioNTech COVID‑19 Vaccine. Pfizer Inc. will provide to all relevant stakeholders a copy of this letter of authorization and communicate any subsequent amendments that might be made to this letter of authorization and its authorized labeling.

D. Pfizer Inc. may develop and disseminate instructional and educational materials (e.g., video regarding vaccine handling, storage/cold-chain management, preparation, disposal) that are consistent with the authorized emergency use of the vaccine as described in the letter of authorization and authorized labeling, without FDA’s review and concurrence, when necessary to meet public health needs during an emergency. Any instructional and educational materials that are inconsistent with the authorized labeling are prohibited.

E. Pfizer Inc. may request changes to this authorization, including to the authorized Fact Sheets for the Pfizer COVID-19 Vaccine. Any request for changes to this EUA must be submitted to Office of Vaccines Research and Review (OVRR)/Center for Biologics Evaluation and Research (CBER). Such changes require appropriate authorization prior to implementation.8

F. Pfizer Inc. will report to Vaccine Adverse Event Reporting System (VAERS): • Serious adverse events (irrespective of attribution to vaccination); • Cases of Multisystem Inflammatory Syndrome in children and adults; and • Cases of COVID-19 that result in hospitalization or death, that are reported to Pfizer Inc. These reports should be submitted to VAERS as soon as possible but no later than 15 calendar days from initial receipt of the information by Pfizer Inc.

G. Pfizer Inc. must submit to Investigational New Drug application (IND) number 19736 periodic safety reports at monthly intervals in accordance with a due date agreed upon with the Office of Biostatistics and Epidemiology (OBE)/CBER beginning after the first full calendar month after authorization. Each periodic safety report is required to contain descriptive information which includes: • A narrative summary and analysis of adverse events submitted during the reporting interval, including interval and cumulative counts by age groups, special populations (e.g., pregnant women), and adverse events of special interest; • A narrative summary and analysis of vaccine administration errors, whether or not associated with an adverse event, that were identified since the last reporting interval;

8 The following types of revisions may be authorized without reissuing this letter: (1) changes to the authorized labeling; (2) non-substantive editorial corrections to this letter; (3) new types of authorized labeling, including new fact sheets; (4) new carton/container labels; (5) expiration dating extensions; (6) changes to manufacturing processes, including tests or other authorized components of manufacturing; (7) new conditions of authorization to require data collection or study. For changes to the authorization, including the authorized labeling, of the type listed in (3), (6), or (7), review and concurrence is required from the Preparedness and Response Team (PREP)/Office of the Center Director (OD)/CBER and the Office of Counterterrorism and Emerging Threats (OCET)/Office of the Chief Scientist (OCS).

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• Newly identified safety concerns in the interval; and • Actions taken since the last report because of adverse experiences (for example, changes made to Healthcare Providers Administering Vaccine (Vaccination Providers) Fact Sheet, changes made to studies or studies initiated). H. No changes will be implemented to the description of the product, manufacturing process, facilities, or equipment without notification to and concurrence by the Agency.

I. All manufacturing facilities will comply with Current Good Manufacturing Practice requirements.

J. Pfizer Inc. will submit to the EUA file Certificates of Analysis (CoA) for each drug product lot at least 48 hours prior to vaccine distribution. The CoA will include the established specifications and specific results for each quality control test performed on the final drug product lot.

K. Pfizer Inc. will submit to the EUA file quarterly manufacturing reports that include a listing of all Drug Substance and Drug Product lots produced after issuance of this authorization. This report must include lot number, manufacturing site, date of manufacture, and lot disposition, including those lots that were quarantined for investigation or those lots that were rejected. Information on the reasons for lot quarantine or rejection must be included in the report. The first report is due July 2021.

L. Pfizer Inc. and authorized distributor(s) will maintain records regarding release of Pfizer-BioNTech COVID‑19 Vaccine for distribution (i.e., lot numbers, quantity, release date).

M. Pfizer Inc. and authorized distributor(s) will make available to FDA upon request any records maintained in connection with this EUA.

N. Pfizer Inc. will conduct post-authorization observational study(ies) to evaluate the association between Pfizer-BioNTech COVID-19 Vaccine and a pre-specified list of adverse events of special interest, along with deaths and hospitalizations, and severe COVID-19. The study population should include individuals administered the authorized Pfizer-BioNTech COVID-19 Vaccine under this EUA in the general U.S. population (16 years of age and older), populations of interest such as healthcare workers, pregnant women, immunocompromised individuals, subpopulations with specific comorbidities. The study(ies) should be conducted in large scale databases with an active comparator. Pfizer Inc. will provide protocols and status update reports to the IND 19736 with agreed-upon study designs and milestone dates.

Emergency Response Stakeholders

O. Emergency response stakeholders will identify vaccination sites to receive authorized Pfizer-BioNTech COVID‑19 Vaccine and ensure its distribution and administration, consistent with the terms of this letter and CDC’s COVID-19 Vaccination Program.

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P. Emergency response stakeholders will ensure that vaccination providers within their jurisdictions are aware of this letter of authorization, and the terms herein and any subsequent amendments that might be made to the letter of authorization, instruct them about the means through which they are to obtain and administer the vaccine under the EUA, and ensure that the authorized labeling [i.e., Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers] is made available to vaccination providers through appropriate means (e.g., e-mail, website).

Q. Emergency response stakeholders receiving authorized Pfizer-BioNTech COVID‑19 Vaccine will ensure that appropriate storage and cold chain is maintained.

Vaccination Providers

R. Vaccination providers will administer the vaccine in accordance with the authorization and will participate and comply with the terms and training required by CDC’s COVID-19 Vaccination Program.

S. Vaccination providers will provide the Fact Sheet for Recipients and Caregivers to each individual receiving vaccination and provide the necessary information for receiving their second dose.

T. Vaccination providers administering Pfizer-BioNTech COVID‑19 Vaccine must report the following information associated with the administration of Pfizer- BioNTech COVID‑19 Vaccine of which they become aware to VAERS in accordance with the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): • Vaccine administration errors whether or not associated with an adverse event • Serious adverse events (irrespective of attribution to vaccination) • Cases of Multisystem Inflammatory Syndrome in children and adults • Cases of COVID-19 that result in hospitalization or death Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. The VAERS reports should include the words “Pfizer-BioNTech COVID‑19 Vaccine EUA” in the description section of the report. More information is available at vaers.hhs.gov or by calling 1-800-822- 7967. To the extent feasible, report to Pfizer Inc. by contacting 1-800-438-1985 or by providing a copy of the VAERS form to Pfizer Inc.; Fax: 1-866-635-8337. U. Vaccination providers will conduct any follow-up requested by the U.S government, including CDC, FDA, or other designee, regarding adverse events to the extent feasible given the emergency circumstances.

V. Vaccination providers will monitor and comply with CDC and/or emergency response stakeholder vaccine management requirements (e.g., requirements

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concerning obtaining, tracking, and handling vaccine) and with requirements concerning reporting of vaccine administration data to CDC.

W. Vaccination providers will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to CDC, and FDA for inspection upon request. Conditions Related to Printed Matter, Advertising, and Promotion

X. All descriptive printed matter, advertising, and promotional material, relating to the use of the Pfizer-BioNTech COVID‑19 Vaccine shall be consistent with the authorized labeling, as well as the terms set forth in this EUA, and meet the requirements set forth in section 502(a) and (n) of the FD&C Act and FDA implementing regulations.

Y. All descriptive printed matter, advertising, and promotional material relating to the use of the Pfizer-BioNTech COVID‑19 Vaccine clearly and conspicuously shall state that: • This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older; and • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

IV. Duration of Authorization

This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.

Sincerely,

--/S/--

______RADM Denise M. Hinton Chief Scientist Food and Drug Administration

Enclosures

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EXHIBIT “B”

Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 33 of 104 Page ID #:33

December 18, 2020

ModernaTX, Inc. Attention: Ms. Carlota Vinals 200 Technology Square Cambridge, MA 02139

Dear Ms. Vinals:

This letter is in response to a request from ModernaTX, Inc. that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of Moderna COVID‑19 Vaccine for the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older, as described in the Scope of Authorization (Section II) of this letter, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act) (21 U.S.C. 360bbb-3).

On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. 1 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Act, subject to terms of any authorization issued under that section. 2

Moderna COVID‑19 Vaccine is for use for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. The vaccine contains a nucleoside-modif ie d messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid particles. It is an investigational vaccine not licensed for any indication.

FDA reviewed safety and efficacy data from an ongoing phase 3 trial in approximately 30,000 participants randomized 1:1 to receive Moderna COVID‑19 Vaccine or saline control. The trial has enrolled participants 18 years of age and older.

1 U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. February 4, 2020. 2 U.S. Department of Health and Human Services, Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3, 85 FR 18250 (April 1, 2020).

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FDA’s review of the available safety data from 30,351 participants 18 years of age and older, who were followed for a median of 7 weeks after receiving the second dose, did not identify specific safety concerns that would preclude issuance of an EUA. Review of additional safety data from these participants with a median of 9 weeks of follow-up after receipt of the second dose did not change FDA’s assessment of safety of the vaccine.

FDA’s analysis of the efficacy data from 28,207 participants 18 years of age and older without evidence of SARS-CoV-2 infection prior to dose 1 confirms the vaccine was 94.1% effective (95% confidence interval (CI) 89.3, 96.8) in preventing COVID-19 occurring at least 14 days after the second dose (with 11 COVID-19 cases in the vaccine group compared to 185 COVID- 19 cases in the placebo group). In this final scheduled analysis participants had been followed for a median of 9 weeks following the second dose. This result is consistent with that obtained from an interim analysis of efficacy conducted after these participants had been followed for a median of 7 weeks after the second dose (vaccine efficacy 94.5%, 95% CI: 86.5, 97.8).

Based on the safety and effectiveness data, and review of manufacturing information regarding product quality and consistency, it is reasonable to believe that Moderna COVID‑19 Vaccine may be effective. Additionally, it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of Moderna COVID‑19 Vaccine outweigh the known and potential risks of the vaccine, for the prevention of COVID-19 in individuals 18 years of age and older. Finally, on December 17, 2020, the Vaccines and Related Biological Products Advisory Committee voted in agreement with this conclusion.

Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Moderna COVID-19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization.

I. Crite ria for Issuance of Authorization

I have concluded that the emergency use of Moderna COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:

1. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;

2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Moderna COVID‑19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Moderna COVID‑19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and

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3. There is no adequate, approved, and available alternative to the emergency use of Moderna COVID-19 Vaccine to prevent COVID-19.3

II. Scope of Authorization

I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited as follows:

• ModernaTX, Inc. will supply Moderna COVID‑19 Vaccine either directly or through authorized distributor(s)4, to emergency response stakeholders 5 as directed by the U.S. government, including the Centers for Disease Control and Prevention (CDC) and/or other designee, for use consistent with the terms and conditions of this EUA; • The Moderna COVID‑19 Vaccine covered by this authorization will be administered by vaccination providers 6 and used only to prevent COVID-19 in individuals ages 18 and older; and • The Moderna COVID‑19 Vaccine may be administered by a vaccination provider without an individual prescription for each vaccine recipient.

3 No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.

4 “Authorized Distributor(s)” are identified by ModernaTX, Inc. or, if applicable, by a U.S. government entity, such as the Centers for Disease Control and Prevention (CDC) and/or other designee, as an entity or entities allowed to distribute authorized Moderna COVID‑19 Vaccine. 5 For purposes of this letter, “emergency response stakeholder” refers to a public health agency and its delegates that have legal responsibility and authority for responding to an incident, based on political or geographical boundary lines (e.g., city, county, tribal, territorial, State, or Federal), or functional (e.g., law enforcement or public health range) or sphere of authority to administer, deliver, or distribute vaccine in an emergency situation. In some cases (e.g., depending on a state or local jurisdiction’s COVID-19 vaccination response organization and plans), there might be overlapping roles and responsibilities among “emergency response stakeholders” and “vaccination providers” (e.g., if a local health department is administering COVID-19 vaccines; if a pharmacy is acting in an official capacity under the authority of the state health department to administer COVID-19 vaccines). In such cases, it is expected that the conditions of authorization that apply to emergency response stakeholders and vaccination providers will all be met. 6 For purposes of this letter, “vaccination provider” refers to the facility, organization, or healthcare provider licensed or otherwise authorized by the emergency response stakeholder (e.g., non-physician healthcare professionals, such as nurses and pharmacists pursuant to state law under a standing order issued by the state health officer) to administer or provide vaccination services in accordance with the applicable emergency response stakeholder’s official COVID-19 vaccination and emergency response plan(s) and who is enrolled in the CDC COVID-19 Vaccination Program. For purposes of this letter, “healthcare provider” also refers to a person authorized by the U.S. Department of Health and Human Services (e.g., under the PREP Act Declaration for Medical Countermeasures against COVID-19) to administer FDA-authorized COVID-19 vaccine (e.g., qualified pharmacy technicians and State-authorized pharmacy interns acting under the supervision of a qualified pharmacist). See, e.g., HHS. Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of the Declaration. 85 FR 79190 (December 9, 2020).

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Product Description

The Moderna COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials.. The Moderna COVID-19 Vaccine does not contain a preservative.

Each 0.5 mL dose of the Moderna COVID-19 Vaccine contains 100 mcg of a nucleoside- modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. Each dose of the Moderna COVID-19 Vaccine also includes the following ingredients: lipids (SM-102; 1,2- dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 [PEG2000-DMG]; cholesterol; and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose.

The dosing regimen is two doses of 0.5 mL each, one month apart.

The manufacture of the authorized Moderna COVID‑19 Vaccine is limited to those facilities identified and agreed upon in the ModernaTX, Inc. request for authorization.

The Moderna COVID-19 Vaccine vial label and carton labels are clearly marked for “Emergency Use Authorization.” The Moderna COVID‑19 Vaccine is authorized to be distributed, stored, further redistributed, and administered by emergency response stakeholders when packaged in the authorized manufacturer packaging (i.e., vials and cartons), despite the fact that the vial and carton labels may not contain information that otherwise would be required under the FD&C Act.

The Moderna COVID‑19 Vaccine is authorized for emergency use with the following product- specific information required to be made available to vaccination providers and recipients, respectively (referred to as “authorized labeling”):

• Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) of the Moderna COVID‑19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19)

• Fact Sheet for Recipients and Caregivers: Emergency Use Authorization (EUA) of the Moderna COVID‑19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) in Individuals 18 Years of Age and Older

I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of Moderna COVID‑19 Vaccine, when used to prevent COVID-19 and used in accordance with this Scope of Authorization (Section II), outweigh its known and potential risks.

I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that Moderna COVID‑19 Vaccine may be effective in preventing COVID-19 when used in accordance with this Scope of Authorization (Section II), pursuant to Section 564(c)(2)(A) of the Act.

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Having reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section I above, I have concluded that Moderna COVID‑19 Vaccine (as described in this Scope of Authorization (Section II)) meets the criteria set forth in Section 564(c) of the Act concerning safety and potential effectiveness.

The emergency use of Moderna COVID‑19 Vaccine under this EUA must be consistent with, and may not exceed, the terms of the Authorization, including the Scope of Authorization (Section II) and the Conditions of Authorization (Section III). Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination under Section 564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under Section 564(b)(1), Moderna COVID‑19 Vaccine is authorized to prevent COVID-19 in individuals 18 years of age and older as described in the Scope of Authorization (Section II) under this EUA, despite the fact that it does not meet certain requirements otherwise required by applicable federal law.

III. Conditions of Authorization

Pursuant to Section 564 of the Act, I am establishing the following conditions on this authorization:

ModernaTX, Inc. and Authorized Distributor(s)

A. ModernaTX, Inc. and authorized distributor(s) will ensure that the authorized Moderna COVID‑19 Vaccine is distributed, as directed by the U.S. government, including CDC and/or other designee, and the authorized labeling (i.e., Fact Sheets) will be made available to vaccination providers, recipients, and caregivers consistent with the terms of this letter.

B. ModernaTX, Inc. and authorized distributor(s) will ensure that appropriate storage and cold chain is maintained until delivered to emergency response stakeholders’ receipt sites.

C. ModernaTX, Inc. will ensure that the terms of this EUA are made available to all relevant stakeholders (e.g., emergency response stakeholders, authorized distributors, and vaccination providers) involved in distributing or receiving authorized Moderna COVID‑19 Vaccine. ModernaTX, Inc. will provide to all relevant stakeholders a copy of this letter of authorization and communicate any subsequent amendments that might be made to this letter of authorization and its authorized labeling.

D. ModernaTX, Inc. may develop and disseminate instructional and educational materials (e.g., video regarding vaccine handling, storage/cold-chain management, preparation, disposal) that are consistent with the authorized emergency use of the vaccine as described in the letter of authorization and authorized labeling, without FDA’s review and concurrence, when necessary to meet public health needs during an emergency. Any instructional and educational materials that are inconsistent with the authorized labeling are prohibited.

E. ModernaTX, Inc. may request changes to this authorization, including to the authorized Fact Sheets for Moderna COVID‑19 Vaccine, that do not alter the analysis

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of benefits and risks that underlies this authorization and FDA may determine that such changes may be permitted without amendment of this EUA. That determination must be made by joint decision of the Office of Vaccines Research and Review (OVRR)/Center for Biologics Evaluation and Research (CBER), the Preparedness and Response Team (PREP)/Office of the Center Director (OD)/CBER, and the Office of Counterterrorism and Emerging Threats (OCET)/Office of the Chief Scientist/Office of the Commissioner (OCS).

F. ModernaTX, Inc. will report to Vaccine Adverse Event Reporting System (VAERS): • Vaccine administration errors whether or not associated with an adverse event; • Serious adverse events (irrespective of attribution to vaccination); • Cases of Multisystem Inflammatory Syndrome in adults; and • Cases of COVID-19 that result in hospitalization or death, that are reported to ModernaTX, Inc. These reports should be submitted to VAERS as soon as possible but no later than 15 calendar days from initial receipt of the information by ModernaTX, Inc.

G. ModernaTX, Inc. must submit to Investigational New Drug application (IND) number 19745 periodic safety reports at monthly intervals, within 15 days after the last day of a month, beginning after the first full calendar month after authorization. Each periodic safety report is required to contain descriptive information which includes: • A narrative summary and analysis of adverse events submitted during the reporting interval, including interval and cumulative counts by age groups, special populations (e.g., pregnant women), and adverse events of special interest. • Newly identified safety concerns in the interval; and • Actions taken since the last report because of adverse experiences (for example, changes made to Healthcare Providers Administering Vaccine (Vaccination Providers) Fact Sheet, changes made to studies or studies initiated).

H. No changes will be implemented to the description of the product, manufacturing process, facilities, or equipment without notification to and concurrence by the Agency.

I. All manufacturing facilities will comply with Current Good Manufacturing Practice requirements.

J. ModernaTX, Inc. will submit to the EUA file Certificates of Analysis (CoA) for each drug product lot at least 48 hours prior to vaccine distribution. The CoA will include the established specifications and specific results for each quality control test performed on the final drug product lot.

K. ModernaTX, Inc. will submit to the EUA file quarterly manufacturing reports that include a listing of all Drug Substance and Drug Product lots produced after issuance of this authorization. This report must include lot number, manufacturing site, date of manufacture, and lot disposition, including those lots that were quarantined for investigation or those lots that were rejected. Information on the reasons for lot

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quarantine or rejection must be included in the report. The first report is due July 2021.

L. ModernaTX, Inc. and authorized distributor(s) will maintain records regarding release of Moderna COVID‑19 Vaccine for distribution (i.e., lot numbers, quantity, release date).

M. ModernaTX, Inc. and authorized distributor(s) will make available to FDA upon request any records maintained in connection with this EUA.

N. ModernaTX, Inc. will conduct post-authorization observational studies to evaluate the association between Moderna COVID-19 Vaccine and a pre-specified list of adverse events of special interest, along with deaths and hospitalizations, and severe COVID-19. The study population should include individuals administered the authorized Moderna COVID-19 Vaccine under this EUA in the general U.S. population (18 years of age and older), populations of interest such as healthcare workers, pregnant women, immunocompromised individuals, subpopulations with specific comorbidities. The studies should be conducted in large scale databases with an active comparator. ModernaTX, Inc. will provide protocols and status update reports to the IND 19745 with agreed-upon study designs and milestone dates.

O. ModernaTX, Inc., working with its contract research organization, will continue to monitor the performance of its clinical investigators in ongoing clinical studies of its vaccine and will report to FDA promptly any significant deviations from the protocols.

Emergency Response Stakeholders

P. Emergency response stakeholders will identify vaccination sites to receive authorized Moderna COVID‑19 Vaccine and ensure its distribution and administration, consistent with the terms of this letter and CDC’s COVID-19 Vaccination Program.

Q. Emergency response stakeholders will ensure that vaccination providers within their jurisdictions are aware of this letter of authorization, and the terms herein and any subsequent amendments that might be made to the letter of authorization, instruct them about the means through which they are to obtain and administer the vaccine under the EUA, and ensure that the authorized labeling [i.e., Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers] is made available to vaccination providers through appropriate means (e.g., e-mail, website).

R. Emergency response stakeholders receiving authorized Moderna COVID‑19 Vaccine will ensure that appropriate storage and cold chain is maintained.

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Vaccination Providers

S. Vaccination providers will administer the vaccine in accordance with the authorization and will participate and comply with the terms and training required by CDC’s COVID-19 Vaccination Program.

T. Vaccination providers will provide the Fact Sheet for Recipients and Caregivers to each individual receiving vaccination and provide the necessary information for receiving their second dose.

U. Vaccination providers administering Moderna COVID‑19 Vaccine must report the following information associated with the administration of Moderna COVID‑19 Vaccine of which they become aware to VAERS in accordance with the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): • Vaccine administration errors whether or not associated with an adverse event • Serious adverse events (irrespective of attribution to vaccination) • Cases of Multisystem Inflammatory Syndrome in adults • Cases of COVID-19 that result in hospitalization or death Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. The VAERS reports should include the words “ Moderna COVID‑19 Vaccine EUA” in the description section of the report. More information is available at vaers.hhs.gov or by calling 1-800-822- 7967. To the extent feasible, report to ModernaTX, Inc., by contacting 1-866-663- 3762, by providing a copy of the VAERS form to ModernaTX, Inc., Fax: 1-866- 599-1342 or by email; [email protected]. V. Vaccination providers will conduct any follow-up requested by the U.S government, including CDC, FDA, or other designee, regarding adverse events to the extent feasible given the emergency circumstances.

W. Vaccination providers will monitor and comply with CDC and/or emergency response stakeholder vaccine management requirements (e.g., requirements concerning obtaining, tracking, and handling vaccine) and with requirements concerning reporting of vaccine administration data to CDC.

X. Vaccination providers will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to CDC and FDA for inspection upon request.

Conditions Related to Printed Matter, Advertising, and Promotion

Y. All descriptive printed matter, advertising, and promotional material relating to the use of the Moderna COVID‑19 Vaccine shall be consistent with the authorized

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labeling, as well as the terms set forth in this EUA, and meet the requirements set forth in section 502(a) and (n) of the FD&C Act and FDA implementing regulations.

Z. All descriptive printed matter, advertising, and promotional material relating to the use of the Moderna COVID‑19 Vaccine clearly and conspicuously shall state that: • This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 18 years of age and older; and • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

IV. Duration of Authorization

Sincerely,

--/S/-- ______RADM Denise M. Hinton Chief Scientist Food and Drug Administration

Enclosures

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EXHIBIT “C”

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February 27, 2021

Janssen Biotech, Inc. Attention: Ms. Ruta Walawalkar 920 Route 202 Raritan, NJ 08869

Dear Ms. Walawalkar:

This letter is in response to a request from Janssen Biotech, Inc. that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the Janssen COVID‑19 Vaccine for the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older, as described in the Scope of Authorization (Section II) of this letter, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act) (21 U.S.C. 360bbb-3).

On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19.1 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Act, subject to terms of any authorization issued under that section.2

The Janssen COVID‑19 Vaccine is for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. The vaccine contains a recombinant, replication-incompetent human adenovirus serotype 26 (Ad26) vector, encoding the SARS-CoV-2 viral spike (S) glycoprotein, stabilized in its pre-fusion form. It is an investigational vaccine not licensed for any indication.

FDA reviewed safety and efficacy data from an ongoing phase 3 trial which has enrolled 43,783 participants randomized 1:1 to receive Janssen COVID‑19 Vaccine or saline control. The trial has enrolled participants 18 years of age and older. FDA’s review has considered the safety and effectiveness data as they relate to the request for emergency use authorization. FDA’s review of the available safety data from 43,783 participants 18 years of age and older, who were followed

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for a median duration of eight weeks after receiving the vaccine or placebo, did not identify specific safety concerns that would preclude issuance of an EUA. FDA’s analysis of the efficacy data from 39,321 participants 18 years of age and older who were SARS-CoV-2 seronegative or who had an unknown serostatus at baseline show that the vaccine was 66.9% effective (95% confidence interval (CI): 59.0, 73.4) and 66.1% effective (95% CI: 55.0, 74.8) in preventing moderate to severe/critical COVID-19 occurring at least 14 days and at least 28 days after vaccination, respectively. Based on these data, and review of manufacturing information regarding product quality and consistency, it is reasonable to believe that the Janssen COVID‑19 Vaccine may be effective. Additionally, it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of the Janssen COVID‑19 Vaccine outweigh its known and potential risks, for the prevention of COVID-19 in individuals 18 years of age and older. Finally, on February 26, 2021, the Vaccines and Related Biological Products Advisory Committee voted in agreement with this conclusion.

Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of the Janssen COVID‑19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization.

I. Criteria for Issuance of Authorization

I have concluded that the emergency use of the Janssen COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:

1. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;

2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the Janssen COVID‑19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of the Janssen COVID‑19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and

3. There is no adequate, approved, and available alternative to the emergency use of the Janssen COVID‑19 Vaccine to prevent COVID-19.3

II. Scope of Authorization

I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited as follows:

3 No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.

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• Janssen Biotech, Inc. will supply the Janssen COVID‑19 Vaccine, either directly or through authorized distributor(s)4 to emergency response stakeholders5 as directed by the U.S. government, including the Centers for Disease Control and Prevention (CDC) and/or other designee, for use consistent with the terms and conditions of this EUA; • The Janssen COVID‑19 Vaccine covered by this authorization will be administered by vaccination providers6 and used only to prevent COVID-19 in individuals ages 18 and older; and • The Janssen COVID‑19 Vaccine may be administered by a vaccination provider without an individual prescription for each vaccine recipient.

Product Description

The Janssen COVID-19 Vaccine is supplied as a suspension in multi-dose vials. The Janssen COVID-19 Vaccine does not contain a preservative.

Each 0.5 mL dose of the Janssen COVID-19 Vaccine is formulated to contain 5x1010 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Janssen COVID-19 Vaccine also includes the following inactive ingredients 2.19 mg sodium chloride, 0.14 mg citric acid monohydrate, 2.02 mg trisodium citrate dihydrate, 0.16 mg

4 “Authorized Distributor(s)” are identified by Janssen Biotech, Inc.or, if applicable, by a U.S. government entity, such as the Centers for Disease Control and Prevention (CDC) and/or other designee, as an entity or entities allowed to distribute authorized Janssen COVID‑19 Vaccine.

5 For purposes of this letter, “emergency response stakeholder” refers to a public health agency and its delegates that have legal responsibility and authority for responding to an incident, based on political or geographical boundary lines (e.g., city, county, tribal, territorial, State, or Federal), or functional (e.g., law enforcement or public health range) or sphere of authority to administer, deliver, or distribute vaccine in an emergency situation. In some cases (e.g., depending on a state or local jurisdiction’s COVID-19 vaccination response organization and plans), there might be overlapping roles and responsibilities among “emergency response stakeholders” and “vaccination providers” (e.g., if a local health department is administering COVID-19 vaccines; if a pharmacy is acting in an official capacity under the authority of the state health department to administer COVID-19 vaccines). In such cases, it is expected that the conditions of authorization that apply to emergency response stakeholders and vaccination providers will all be met.

6 For purposes of this letter, “vaccination provider” refers to the facility, organization, or healthcare provider licensed or otherwise authorized by the emergency response stakeholder (e.g., non-physician healthcare professionals, such as nurses and pharmacists pursuant to state law under a standing order issued by the state health officer) to administer or provide vaccination services in accordance with the applicable emergency response stakeholder’s official COVID-19 vaccination and emergency response plan(s) and who is enrolled in the CDC COVID-19 Vaccination Program. For purposes of this letter, “healthcare provider” also refers to a person authorized by the U.S. Department of Health and Human Services (e.g., under the PREP Act Declaration for Medical Countermeasures against COVID-19) to administer FDA-authorized COVID-19 vaccine (e.g., qualified pharmacy technicians and State-authorized pharmacy interns acting under the supervision of a qualified pharmacist). See, e.g., HHS. Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of the Declaration. 85 FR 79190 (December 9, 2020).

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polysorbate-80, 25.5 mg 2-hydroxypropyl--cyclodextrin, 2.04 mg ethanol. Each dose may also contain residual amounts of host cell proteins (≤0.15 mcg) and/or host cell DNA (≤3 ng).

The dosing regimen is a single dose of 0.5 mL

The manufacture of the authorized Janssen COVID‑19 Vaccine is limited to those facilities identified and agreed upon in Janssen’s request for authorization.

The Janssen COVID-19 Vaccine vial label and carton labels are clearly marked for “Emergency Use Authorization.” The Janssen COVID‑19 Vaccine is authorized to be distributed, stored, further redistributed, and administered by emergency response stakeholders when packaged in the authorized manufacturer packaging (i.e., vials and cartons), despite the fact that the vial and carton labels may not contain information that otherwise would be required under the FD&C Act.

The Janssen COVID‑19 Vaccine is authorized for emergency use with the following product- specific information required to be made available to vaccination providers and recipients, respectively (referred to as “authorized labeling”):

• Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) of the Janssen COVID‑19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19)

• Fact Sheet for Recipients and Caregivers: Emergency Use Authorization (EUA) of the Janssen COVID‑19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) in Individuals 18 Years of Age and Older

I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the Janssen COVID‑19 Vaccine, when used to prevent COVID-19 and used in accordance with this Scope of Authorization (Section II), outweigh its known and potential risks.

I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the Janssen COVID‑19 Vaccine may be effective in preventing COVID-19 when used in accordance with this Scope of Authorization (Section II), pursuant to Section 564(c)(2)(A) of the Act.

Having reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section I above, I have concluded that the Janssen COVID‑19 Vaccine (as described in this Scope of Authorization (Section II)) meets the criteria set forth in Section 564(c) of the Act concerning safety and potential effectiveness.

The emergency use of the Janssen COVID‑19 Vaccine under this EUA must be consistent with, and may not exceed, the terms of the Authorization, including the Scope of Authorization (Section II) and the Conditions of Authorization (Section III). Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination under Section 564(b)(1)(C)

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described above and the Secretary of HHS’s corresponding declaration under Section 564(b)(1), the Janssen COVID‑19 Vaccine is authorized to prevent COVID-19 in individuals 18 years of age and older as described in the Scope of Authorization (Section II) under this EUA, despite the fact that it does not meet certain requirements otherwise required by applicable federal law.

III. Conditions of Authorization

Pursuant to Section 564 of the Act, I am establishing the following conditions on this authorization:

Janssen Biotech, Inc. and Authorized Distributor(s)

A. Janssen Biotech, Inc. and authorized distributor(s) will ensure that the authorized Janssen COVID‑19 Vaccine is distributed, as directed by the U.S. government, including CDC and/or other designee, and the authorized labeling (i.e., Fact Sheets) will be made available to vaccination providers, recipients, and caregivers consistent with the terms of this letter.

B. Janssen Biotech, Inc. and authorized distributor(s) will ensure that appropriate storage and cold chain is maintained until delivered to emergency response stakeholders’ receipt sites.

C. Janssen Biotech, Inc. will ensure that the terms of this EUA are made available to all relevant stakeholders (e.g., emergency response stakeholders, authorized distributors, and vaccination providers) involved in distributing or receiving the authorized Janssen COVID‑19 Vaccine. Janssen Biotech, Inc. will provide to all relevant stakeholders a copy of this letter of authorization and communicate any subsequent amendments that might be made to this letter of authorization and its authorized labeling.

D. Janssen Biotech, Inc. may develop and disseminate instructional and educational materials (e.g., video regarding vaccine handling, storage/cold-chain management, preparation, disposal) that are consistent with the authorized emergency use of the vaccine as described in the letter of authorization and authorized labeling, without FDA’s review and concurrence, when necessary to meet public health needs during an emergency. Any instructional and educational materials that are inconsistent with the authorized labeling are prohibited.

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E. Janssen Biotech, Inc. may request changes to this authorization, including to the authorized Fact Sheets for the Janssen COVID-19 Vaccine. Any request for changes to this EUA must be submitted to the Office of Vaccines Research and Review (OVRR)/Center for Biologics Evaluation and Research (CBER). Such changes require appropriate authorization prior to implementation.7

F. Janssen Biotech, Inc. will report to Vaccine Adverse Event Reporting System (VAERS): • Serious adverse events (irrespective of attribution to vaccination); • Cases of Multisystem Inflammatory Syndrome in adults; and • Cases of COVID-19 that result in hospitalization or death, that are reported to Janssen Biotech, Inc. These reports should be submitted to VAERS as soon as possible but no later than 15 calendar days from initial receipt of the information by Janssen Biotech, Inc.

G. Janssen Biotech, Inc. must submit to Investigational New Drug application (IND) number 22657 periodic safety reports at monthly intervals in accordance with a due date agreed upon with the Office of Biostatistics and Epidemiology (OBE)/CBER, beginning after the first full calendar month after authorization. Each periodic safety report is required to contain descriptive information which includes: • A narrative summary and analysis of adverse events submitted during the reporting interval, including interval and cumulative counts by age groups, special populations (e.g., pregnant women), and adverse events of special interest. • A narrative summary and analysis of vaccine administration errors, whether or not associated with an adverse event, that were identified since the last reporting interval • Newly identified safety concerns in the interval; and • Actions taken since the last report because of adverse experiences (for example, changes made to Healthcare Providers Administering Vaccine (Vaccination Providers) Fact Sheet, changes made to studies or studies initiated).

H. No changes will be implemented to the description of the product, manufacturing process, facilities, or equipment without notification to and concurrence by the Agency.

I. All manufacturing facilities will comply with Current Good Manufacturing Practice requirements.

7 The following types of revisions may be authorized without reissuing this letter: (1) changes to the authorized labeling; (2) non-substantive editorial corrections to this letter; (3) new types of authorized labeling, including new fact sheets; (4) new carton/container labels; (5) expiration dating extensions; (6) changes to manufacturing processes, including tests or other authorized components of manufacturing; (7) new conditions of authorization to require data collection or study. All changes to the authorization require review and concurrence from OVRR. For changes to the authorization, including the authorized labeling, of the type listed in (3), (6), or (7), review and concurrence is also required from the Preparedness and Response Team (PREP)/Office of the Center Director (OD)/CBER and the Office of Counterterrorism and Emerging Threats/Office of the Chief Scientist.

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J. Janssen Biotech, Inc. will submit to the EUA file Certificates of Analysis (CoA) for each drug product lot at least 48 hours prior to vaccine distribution. The CoA will include the established specifications and specific results for each quality control test performed on the final drug product lot.

K. Janssen Biotech, Inc. will submit to the EUA file quarterly manufacturing reports that include a listing of all Drug Substance and Drug Product lots produced after issuance of this authorization. This report must include lot number, manufacturing site, date of manufacture, and lot disposition, including those lots that were quarantined for investigation or those lots that were rejected. Information on the reasons for lot quarantine or rejection must be included in the report. The first report is due June 1, 2021.

L. Janssen Biotech, Inc. and authorized distributor(s) will maintain records regarding release of Janssen COVID‑19 Vaccine for distribution (i.e., lot numbers, quantity, release date).

M. Janssen Biotech, Inc. and authorized distributor(s) will make available to FDA upon request any records maintained in connection with this EUA.

N. Janssen Biotech, Inc. will conduct post-authorization observational studies to evaluate the association between Janssen COVID-19 Vaccine and a pre-specified list of adverse events of special interest, along with deaths and hospitalizations, and severe COVID-19. The study population should include individuals administered the authorized Janssen COVID-19 Vaccine under this EUA in the general U.S. population (18 years of age and older), populations of interest such as healthcare workers, pregnant women, immunocompromised individuals, subpopulations with specific comorbidities. The studies should be conducted in large scale databases with an active comparator. Janssen Biotech, Inc. will provide protocols and status update reports to the IND 22657 with agreed-upon study designs and milestone dates.

Emergency Response Stakeholders

O. Emergency response stakeholders will identify vaccination sites to receive authorized Janssen COVID‑19 Vaccine and ensure its distribution and administration, consistent with the terms of this letter and CDC’s COVID-19 Vaccination Program.

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Q. Emergency response stakeholders receiving authorized Janssen COVID‑19 Vaccine will ensure that appropriate storage and cold chain is maintained.

Vaccination Providers

R. Vaccination providers will administer the vaccine in accordance with the authorization and will participate and comply with the terms and training required by CDC’s COVID-19 Vaccination Program.

S. Vaccination providers will provide the Fact Sheet for Recipients and Caregivers to each individual receiving vaccination.

T. Vaccination providers administering the Janssen COVID‑19 Vaccine must report the following information associated with the administration of the Janssen COVID‑19 Vaccine of which they become aware to VAERS in accordance with the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): • Vaccine administration errors whether or not associated with an adverse event • Serious adverse events (irrespective of attribution to vaccination) • Cases of Multisystem Inflammatory Syndrome in adults • Cases of COVID-19 that result in hospitalization or death Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. The VAERS reports should include the words “Janssen COVID‑19 Vaccine EUA” in the description section of the report. More information is available at vaers.hhs.gov or by calling 1-800-822-7967. To the extent feasible, report to Janssen Biotech, Inc. by contacting 1-800-565-4008 or by providing a copy of the VAERS form to Janssen Biotech, Inc.; Fax: 215- 293-9955, or by email [email protected]. U. Vaccination providers will conduct any follow-up requested by the U.S. government, including CDC, FDA, or other designee, regarding adverse events to the extent feasible given the emergency circumstances.

V. Vaccination providers will monitor and comply with CDC and/or emergency response stakeholder vaccine management requirements (e.g., requirements concerning obtaining, tracking, and handling vaccine) and with requirements concerning reporting of vaccine administration data to CDC.

W. Vaccination providers will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to CDC, and FDA for inspection upon request.

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Conditions Related to Printed Matter, Advertising, and Promotion

X. All descriptive printed matter, advertising, and promotional material, relating to the use of the Janssen COVID‑19 Vaccine shall be consistent with the authorized labeling, as well as the terms set forth in this EUA, and meet the requirements set forth in section 502(a) and (n) of the FD&C Act and FDA implementing regulations.

Y. All descriptive printed matter, advertising, and promotional material relating to the use of the Janssen COVID‑19 Vaccine clearly and conspicuously shall state that: • This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 18 years of age and older; and • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

IV. Duration of Authorization

Sincerely,

______RADM Denise M. Hinton Chief Scientist Food and Drug Administration

Enclosures

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EXHIBIT “D”

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FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS)

EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 16 years of age and older.

SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS

Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine. See “MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION” for reporting requirements.

The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection administered as a series of two doses (0.3 mL each) 3 weeks apart.

See this Fact Sheet for instructions for preparation and administration. This Fact Sheet may have been updated. For the most recent Fact Sheet, please see www.cvdvaccine.com.

For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine for active immunization against COVID-19, please see www.clinicaltrials.gov.

DESCRIPTION OF COVID-19

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

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DOSAGE AND ADMINISTRATION

Storage and Handling

During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

Do not refreeze thawed vials.

Frozen Vials Prior to Use

Cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials arrive in thermal containers with dry ice. Once received, remove the vial cartons immediately from the thermal container and preferably store in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF) until the expiry date printed on the label. Alternatively, vials may be stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks. Vials must be kept frozen and protected from light until ready to use. Vials stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks may be returned one time to the recommended storage condition of -80ºC to -60ºC (-112ºF to -76ºF). Total cumulative time the vials are stored at -25°C to -15°C (-13°F to 5°F) should be tracked and should not exceed 2 weeks.

If an ultra-low temperature freezer is not available, the thermal container in which the Pfizer-BioNTech COVID-19 Vaccine arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. The thermal container maintains a temperature range of -90ºC to -60ºC (-130ºF to -76ºF). Storage of the vials between -96°C to -60°C (-141°F to -76°F) is not considered an excursion from the recommended storage condition.

Transportation of Frozen Vials

If local redistribution is needed and full cartons containing vials cannot be transported at -90°C to -60°C (-130°F to -76°F), vials may be transported at -25°C to -15°C (-13°F to 5°F). Any hours used for transport at -25°C to -15°C (-13°F to 5°F) count against the 2-week limit for storage at -25°C to -15°C (-13°F to 5°F). Frozen vials transported at -25°C to -15°C (-13°F to 5°F) may be returned one time to the recommended storage condition of -80ºC to -60ºC (-112ºF to -76ºF).

Thawed Vials Before Dilution

Thawed Under Refrigeration Thaw and then store undiluted vials in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] for up to 5 days (120 hours). A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time.

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Thawed at Room Temperature For immediate use, thaw undiluted vials at room temperature [up to 25ºC (77ºF)] for 30 minutes. Thawed vials can be handled in room light conditions. Vials must reach room temperature before dilution.

Undiluted vials may be stored at room temperature for no more than 2 hours.

Transportation of Thawed Vials

Available data support transportation of one or more thawed vials at 2°C to 8°C (35°F to 46°F) for up to 12 hours. Any hours used for transport at 2°C to 8°C (35°F to 46°F) count against the 120-hour limit for storage at 2°C to 8°C (35°F to 46°F).

Vials After Dilution

• After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within 6 hours from the time of dilution. • During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. • Any vaccine remaining in vials must be discarded after 6 hours. • Do not refreeze.

Dosing and Schedule

The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.3 mL each) 3 weeks apart.

There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series.

Dose Preparation

Prior to Dilution • The Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vial contains a volume of 0.45 mL, supplied as a frozen suspension that does not contain preservative. Each vial must be thawed and diluted prior to administration. • Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to 25ºC (77ºF)] (see Storage and Handling). • Refer to thawing instructions in the panels below.

Dilution Dilute the vial contents using 1.8 mL of 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. This diluent is not packaged with the vaccine

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and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. Do not add more than 1.8 mL of diluent.

After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. The information in this Fact Sheet regarding the number of doses per vial after dilution supersedes the number of doses stated on vial labels and cartons.

• Refer to dilution and dose preparation instructions in the panels below.

THAWING PRIOR TO DILUTION • Thaw vial(s) of Pfizer-BioNTech COVID-19 Vaccine before use either by: o Allowing vial(s) to thaw in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)]. A carton of vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for up to five days (120 hours). o Allowing vial(s) to sit at room temperature [up to 25ºC (77ºF)] for 30 minutes. • Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours. • Before dilution invert vaccine vial gently 10 times. • Do not shake. • Inspect the liquid in the vial prior to dilution. The liquid is a white to off- white suspension and may contain white to off-white opaque amorphous particles. • Do not use if liquid is discolored or if other particles are observed.

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DILUTION

• Obtain sterile 0.9% Sodium Chloride Injection, USP. Use only this as the diluent. • Using aseptic technique, withdraw 1.8 mL of diluent into a transfer syringe (21-gauge or narrower needle). • Cleanse the vaccine vial stopper with a single-use antiseptic swab. • Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial.

• Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe.

• Gently invert the vial containing the Pfizer-BioNTech COVID-19 Vaccine 10 times to mix. • Do not shake. • Inspect the vaccine in the vial. • The vaccine will be an off-white suspension. Do not use if vaccine is discolored or contains particulate matter.

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• Record the date and time of dilution on the Pfizer-BioNTech COVID-19 Vaccine vial label. • Store between 2°C to 25°C (35°F to 77°F). • Discard any unused vaccine 6 hours after dilution.

PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF PFIZER-BIONTECH COVID-19 VACCINE • Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of the Pfizer-BioNTech COVID-19 Vaccine preferentially using a low dead-volume syringe and/or needle. • Each dose must contain 0.3 mL of vaccine. • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. • Administer immediately.

Administration

Visually inspect each dose in the dosing syringe prior to administration. The vaccine will be an off-white suspension. During the visual inspection, • verify the final dosing volume of 0.3 mL. • confirm there are no particulates and that no discoloration is observed. • do not administer if vaccine is discolored or contains particulate matter.

Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly.

After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine contain six doses of 0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract six doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle:

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• Each dose must contain 0.3 mL of vaccine. • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and content. • Do not pool excess vaccine from multiple vials.

Contraindications

Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine (see Full EUA Prescribing Information).

Warnings

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.

Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical- considerations/managing-anaphylaxis.html).

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.

Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

Adverse Reactions

Adverse Reactions in Clinical Trials Adverse reactions following the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, and lymphadenopathy (see Full EUA Prescribing Information).

Adverse Reactions in Post Authorization Experience Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema) have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.

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Use with Other Vaccines

There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.

INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS

As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the individual to the website www.cvdvaccine.com to obtain the Fact Sheet) prior to the individual receiving each dose of Pfizer-BioNTech COVID-19 Vaccine, including: • FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine, which is not an FDA-approved vaccine. • The recipient or their caregiver has the option to accept or refuse Pfizer-BioNTech COVID-19 Vaccine. • The significant known and potential risks and benefits of Pfizer-BioNTech COVID-19 Vaccine, and the extent to which such risks and benefits are unknown. • Information about available alternative vaccines and the risks and benefits of those alternatives.

For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19, please see www.clinicaltrials.gov.

Provide a vaccination card to the recipient or their caregiver with the date when the recipient needs to return for the second dose of Pfizer-BioNTech COVID-19 Vaccine.

Provide the v-safe information sheet to vaccine recipients/caregivers and encourage vaccine recipients to participate in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information, visit: www.cdc.gov/vsafe.

MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION

In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of Pfizer-BioNTech COVID-19 Vaccine, the following items are required. Use of unapproved Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met):

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1. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 16 years of age and older.

2. The vaccination provider must communicate to the individual receiving the Pfizer-BioNTech COVID-19 Vaccine or their caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” prior to the individual receiving Pfizer-BioNTech COVID-19 Vaccine.

3. The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system.

4. The vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS): • vaccine administration errors whether or not associated with an adverse event, • serious adverse events* (irrespective of attribution to vaccination), • cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and • cases of COVID-19 that result in hospitalization or death.

Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report.

5. The vaccination provider is responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of MIS in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine to recipients.

* Serious adverse events are defined as: • Death; • A life-threatening adverse event; • Inpatient hospitalization or prolongation of existing hospitalization; • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; • A congenital anomaly/birth defect; • An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.

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OTHER ADVERSE EVENT REPORTING TO VAERS AND PFIZER INC.

Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.

To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a copy of the VAERS form to Pfizer Inc.

Website Fax number Telephone number

www.pfizersafetyreporting.com 1-866-635-8337 1-800-438-1985

ADDITIONAL INFORMATION

For general questions, visit the website or call the telephone number provided below.

To access the most recent Pfizer-BioNTech COVID-19 Vaccine Fact Sheets, please scan the QR code provided below.

Global website Telephone number

www.cvdvaccine.com 1-877-829-2619 (1-877-VAX-CO19)

AVAILABLE ALTERNATIVES

There is no approved alternative vaccine to prevent COVID-19. There may be clinical trials or availability under EUA of other COVID-19 vaccines.

AUTHORITY FOR ISSUANCE OF THE EUA

The Secretary of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 pandemic. In response, FDA has issued an EUA for the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization against COVID-19 in individuals 16 years of age and older.

FDA issued this EUA, based on Pfizer-BioNTech’s request and submitted data.

Although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Pfizer-BioNTech COVID-19 Vaccine may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information. Revised: 25 February 2021 10 Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 63 of 104 Page ID #:63

This EUA for the Pfizer-BioNTech COVID-19 Vaccine will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.

For additional information about Emergency Use Authorization visit FDA at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory- and-policy-framework/emergency-use-authorization.

The Countermeasures Injury Compensation Program

The Countermeasures Injury Compensation Program (CICP) is a federal program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. For more information about CICP regarding the Pfizer-BioNTech COVID-19 Vaccine used to prevent COVID-19, visit www.hrsa.gov/cicp, email [email protected], or call: 1-855-266-2427.

Manufactured by Pfizer Inc., New York, NY 10017

Manufactured for BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz, Germany

LAB-1450-5.4

Revised: 25 February 2021

END SHORT VERSION FACT SHEET Long Version (Full EUA Prescribing Information) Begins On Next Page

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FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING

INFORMATION

PFIZER-BIONTECH COVID-19 VACCINE 8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING FULL EMERGENCY USE AUTHORIZATION ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS PRESCRIBING INFORMATION: CONTENTS* 10 DRUG INTERACTIONS 11 USE IN SPECIFIC POPULATIONS 1 AUTHORIZED USE 11.1 Pregnancy 2 DOSAGE AND ADMINISTRATION 11.2 Lactation 2.1 Preparation for Administration 11.3 Pediatric Use 2.2 Administration Information 11.4 Geriatric Use 2.3 Vaccination Schedule for Individuals 16 Years of Age and Older 13 DESCRIPTION 3 DOSAGE FORMS AND STRENGTHS 14 CLINICAL PHARMACOLOGY 4 CONTRAINDICATIONS 14.1 Mechanism of Action 5 WARNINGS AND PRECAUTIONS 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR 5.1 Management of Acute Allergic Reactions EUA 5.2 Altered Immunocompetence 18.1 Efficacy in Participants 16 Years of Age and Older 5.3 Limitation of Effectiveness 19 HOW SUPPLIED/STORAGE AND HANDLING 6 OVERALL SAFETY SUMMARY 20 PATIENT COUNSELING INFORMATION 6.1 Clinical Trials Experience 21 CONTACT INFORMATION 6.2 Post Authorization Experience * Sections or subsections omitted from the full emergency use authorization prescribing information are not listed.

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FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

1 AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Preparation for Administration

Prior to Dilution

• The Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vial contains a volume of 0.45 mL, supplied as a frozen suspension that does not contain preservative. Each vial must be thawed and diluted prior to administration. • Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to 25ºC (77ºF)] [see How Supplied/Storage and Handling (19)]. • Refer to thawing instructions in the panels below.

Dilution

• Dilute the vial contents using 1.8 mL of 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine. Do not add more than 1.8 mL of diluent. • ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. This diluent is not packaged with the vaccine and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. • After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. The information in this Full EUA Prescribing Information regarding the number of doses per vial after dilution supersedes the number of doses stated on vial labels and cartons. • Refer to dilution and dose preparation instructions in the panels below.

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• Before dilution invert vaccine vial gently 10 times. • Do not shake. • Inspect the liquid in the vial prior to dilution. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles. • Do not use if liquid is discolored or if other particles are observed.

DILUTION

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• Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe.

• Record the date and time of dilution on the Pfizer-BioNTech COVID-19 Vaccine vial label. • Store between 2°C to 25°C (35°F to 77°F). • Discard any unused vaccine 6 hours after dilution.

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PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF PFIZER-BIONTECH COVID-19 VACCINE

• Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of the Pfizer-BioNTech COVID-19 Vaccine preferentially using low dead-volume syringes and/or needles. • Each dose must contain 0.3 mL of vaccine. • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. • Administer immediately.

2.2 Administration Information

Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly.

• Each dose must contain 0.3 mL of vaccine. • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. • Do not pool excess vaccine from multiple vials.

2.3 Vaccination Schedule for Individuals 16 Years of Age and Older

The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.3 mL each) three weeks apart.

3 DOSAGE FORMS AND STRENGTHS

Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. After preparation, a single dose is 0.3 mL.

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4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid- 19/clinical-considerations/managing-anaphylaxis.html).

5.2 Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.

5.3 Limitation of Effectiveness

The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

6 OVERALL SAFETY SUMMARY

It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination with the Pfizer-BioNTech COVID-19 Vaccine. To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and Pfizer Inc.

In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%).

Severe allergic reactions, including anaphylaxis, have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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The safety of Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 16 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. Study BNT162-01 (Study 1) was a Phase 1/2, two-part, dose-escalation trial that enrolled 60 participants, 18 through 55 years of age. Study C4591001 (Study 2) is a Phase 1/2/3, multicenter, multinational, randomized, saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy (Phase 2/3) study that has enrolled approximately 44,000 participants, 12 years of age or older. Of these, approximately 43,448 participants (21,720 Pfizer-BioNTech COVID-19 Vaccine; 21,728 placebo) in Phase 2/3 are 16 years of age or older (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively).

At the time of the analysis of Study 2 for the EUA, 37,586 (18,801 Pfizer-BioNTech COVID-19 Vaccine and 18,785 placebo) participants 16 years of age or older have been followed for a median of 2 months after the second dose of Pfizer-BioNTech COVID-19 Vaccine.

The safety evaluation in Study 2 is ongoing. The safety population includes participants enrolled by October 9, 2020, and includes safety data accrued through November 14, 2020. Participants 18 years and older in the reactogenicity subset are monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination in an electronic diary. Participants are being monitored for unsolicited adverse events, including serious adverse events, throughout the study [from Dose 1 through 1 month (all unsolicited adverse events) or 6 months (serious adverse events) after the last vaccination].

Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among participants who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. Overall, among the total participants who received either the Pfizer-BioNTech COVID-19 Vaccine or placebo, 50.6% were male and 49.4% were female, 83.1% were White, 9.1% were Black or African American, 28.0% were Hispanic/Latino, 4.3% were Asian, and 0.5% were American Indian/Alaska Native.

Local and Systemic Adverse Reactions Solicited in the Study 2

Table 1 and Table 2 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of Pfizer-BioNTech COVID-19 Vaccine and placebo in the subset of participants 18 to 55 years of age included in the EUA safety population who were monitored for reactogenicity with an electronic diary.

Table 3 and Table 4 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of each dose of Pfizer-BioNTech COVID-19 Vaccine and placebo for participants 56 years of age and older.

Across both age groups, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days), for redness 2.6 days (range 1 to 34 days), and for swelling 2.3 days (range 1 to 34 days) for participants in the Pfizer-BioNTech COVID-19 Vaccine group.

Solicited reactogenicity data in 16 and 17 year-old participants are limited.

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Table 1: Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 18-55 Years of Age‡ – Reactogenicity Subset of the Safety Population* Pfizer-BioNTech Pfizer-BioNTech COVID-19 Vaccine Placebo COVID-19 Vaccine Placebo Dose 1 Dose 1 Dose 2 Dose 2 Na=2291 Na=2298 Na=2098 Na=2103 nb (%) nb (%) nb (%) nb (%) Rednessc Any (>2 cm) 104 (4.5) 26 (1.1) 123 (5.9) 14 (0.7) Mild 70 (3.1) 16 (0.7) 73 (3.5) 8 (0.4) Moderate 28 (1.2) 6 (0.3) 40 (1.9) 6 (0.3) Severe 6 (0.3) 4 (0.2) 10 (0.5) 0 (0.0) Swellingc Any (>2 cm) 132 (5.8) 11 (0.5) 132 (6.3) 5 (0.2) Mild 88 (3.8) 3 (0.1) 80 (3.8) 3 (0.1) Moderate 39 (1.7) 5 (0.2) 45 (2.1) 2 (0.1) Severe 5 (0.2) 3 (0.1) 7 (0.3) 0 (0.0) Pain at the injection sited Any 1904 (83.1) 322 (14.0) 1632 (77.8) 245 (11.7) Mild 1170 (51.1) 308 (13.4) 1039 (49.5) 225 (10.7) Moderate 710 (31.0) 12 (0.5) 568 (27.1) 20 (1.0) Severe 24 (1.0) 2 (0.1) 25 (1.2) 0 (0.0) Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. b. n = Number of participants with the specified reaction. c. Mild: >2.0 to ≤5.0 cm; Moderate: >5.0 to ≤10.0 cm; Severe: >10.0 cm. d. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity. ‡ Eight participants were between 16 and 17 years of age. * Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.

Table 2: Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 18-55 Years of Age‡ – Safety Population* Pfizer-BioNTech Pfizer-BioNTech COVID-19 Vaccine Placebo COVID-19 Vaccine Placebo Dose 1 Dose 1 Dose 2 Dose 2 Na=2291 Na=2298 Na=2098 Na=2103 nb (%) nb (%) nb (%) nb (%) Fever ≥38.0℃ 85 (3.7) 20 (0.9) 331 (15.8) 10 (0.5) ≥38.0℃ to 38.4℃ 64 (2.8) 10 (0.4) 194 (9.2) 5 (0.2) >38.4℃ to 38.9℃ 15 (0.7) 5 (0.2) 110 (5.2) 3 (0.1) >38.9℃ to 40.0℃ 6 (0.3) 3 (0.1) 26 (1.2) 2 (0.1) >40.0℃ 0 (0.0) 2 (0.1) 1 (0.0) 0 (0.0) Fatiguec Any 1085 (47.4) 767 (33.4) 1247 (59.4) 479 (22.8) Mild 597 (26.1) 467 (20.3) 442 (21.1) 248 (11.8) Moderate 455 (19.9) 289 (12.6) 708 (33.7) 217 (10.3) Severe 33 (1.4) 11 (0.5) 97 (4.6) 14 (0.7)

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Pfizer-BioNTech Pfizer-BioNTech COVID-19 Vaccine Placebo COVID-19 Vaccine Placebo Dose 1 Dose 1 Dose 2 Dose 2 Na=2291 Na=2298 Na=2098 Na=2103 nb (%) nb (%) nb (%) nb (%) Headachec Any 959 (41.9) 775 (33.7) 1085 (51.7) 506 (24.1) Mild 628 (27.4) 505 (22.0) 538 (25.6) 321 (15.3) Moderate 308 (13.4) 251 (10.9) 480 (22.9) 170 (8.1) Severe 23 (1.0) 19 (0.8) 67 (3.2) 15 (0.7) Chillsc Any 321 (14.0) 146 (6.4) 737 (35.1) 79 (3.8) Mild 230 (10.0) 111 (4.8) 359 (17.1) 65 (3.1) Moderate 82 (3.6) 33 (1.4) 333 (15.9) 14 (0.7) Severe 9 (0.4) 2 (0.1) 45 (2.1) 0 (0.0) Vomitingd Any 28 (1.2) 28 (1.2) 40 (1.9) 25 (1.2) Mild 24 (1.0) 22 (1.0) 28 (1.3) 16 (0.8) Moderate 4 (0.2) 5 (0.2) 8 (0.4) 9 (0.4) Severe 0 (0.0) 1 (0.0) 4 (0.2) 0 (0.0) Diarrheae Any 255 (11.1) 270 (11.7) 219 (10.4) 177 (8.4) Mild 206 (9.0) 217 (9.4) 179 (8.5) 144 (6.8) Moderate 46 (2.0) 52 (2.3) 36 (1.7) 32 (1.5) Severe 3 (0.1) 1 (0.0) 4 (0.2) 1 (0.0) New or worsened muscle painc Any 487 (21.3) 249 (10.8) 783 (37.3) 173 (8.2) Mild 256 (11.2) 175 (7.6) 326 (15.5) 111 (5.3) Moderate 218 (9.5) 72 (3.1) 410 (19.5) 59 (2.8) Severe 13 (0.6) 2 (0.1) 47 (2.2) 3 (0.1) New or worsened joint painc Any 251 (11.0) 138 (6.0) 459 (21.9) 109 (5.2) Mild 147 (6.4) 95 (4.1) 205 (9.8) 54 (2.6) Moderate 99 (4.3) 43 (1.9) 234 (11.2) 51 (2.4) Severe 5 (0.2) 0 (0.0) 20 (1.0) 4 (0.2) Use of antipyretic or pain medicationf 638 (27.8) 332 (14.4) 945 (45.0) 266 (12.6) Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. a. N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose. b. n = Number of participants with the specified reaction. c. Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity. d. Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration. e. Mild: 2 to 3 loose stools in 24 hours; Moderate: 4 to 5 loose stools in 24 hours; Severe: 6 or more loose stools in 24 hours. f. Severity was not collected for use of antipyretic or pain medication. ‡ Eight participants were between 16 and 17 years of age. * Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.

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Table 3: Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age and Older – Safety Population* Pfizer-BioNTech Pfizer-BioNTech COVID-19 Vaccine Placebo COVID-19 Vaccine Placebo Dose 1 Dose 1 Dose 2 Dose 2 Na=1802 Na=1792 Na=1660 Na=1646 nb (%) nb (%) nb (%) nb (%) Rednessc Any (>2 cm) 85 (4.7) 19 (1.1) 120 (7.2) 12 (0.7) Mild 55 (3.1) 12 (0.7) 59 (3.6) 8 (0.5) Moderate 27 (1.5) 5 (0.3) 53 (3.2) 3 (0.2) Severe 3 (0.2) 2 (0.1) 8 (0.5) 1 (0.1) Swellingc Any (>2 cm) 118 (6.5) 21 (1.2) 124 (7.5) 11 (0.7) Mild 71 (3.9) 10 (0.6) 68 (4.1) 5 (0.3) Moderate 45 (2.5) 11 (0.6) 53 (3.2) 5 (0.3) Severe 2 (0.1) 0 (0.0) 3 (0.2) 1 (0.1) Pain at the injection sited Any (>2 cm) 1282 (71.1) 166 (9.3) 1098 (66.1) 127 (7.7) Mild 1008 (55.9) 160 (8.9) 792 (47.7) 125 (7.6) Moderate 270 (15.0) 6 (0.3) 298 (18.0) 2 (0.1) Severe 4 (0.2) 0 (0.0) 8 (0.5) 0 (0.0) Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. b. n = Number of participants with the specified reaction. c. Mild: >2.0 to ≤5.0 cm; Moderate: >5.0 to ≤10.0 cm; Severe: >10.0 cm. d. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity. * Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.

Table 4: Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age and Older – Reactogenicity Subset of the Safety Population* Pfizer-BioNTech Pfizer-BioNTech COVID-19 COVID-19 Vaccine Placebo Vaccine Placebo Dose 1 Dose 1 Dose 2 Dose 2 Na=1802 Na=1792 Na=1660 Na=1646 nb (%) nb (%) nb (%) nb (%) Fever ≥38.0℃ 26 (1.4) 7 (0.4) 181 (10.9) 4 (0.2) ≥38.0℃ to 38.4℃ 23 (1.3) 2 (0.1) 131 (7.9) 2 (0.1) >38.4℃ to 38.9℃ 1 (0.1) 3 (0.2) 45 (2.7) 1 (0.1) >38.9℃ to 40.0℃ 1 (0.1) 2 (0.1) 5 (0.3) 1 (0.1) >40.0℃ 1 (0.1) 0 (0.0) 0 (0.0) 0 (0.0) Fatiguec Any 615 (34.1) 405 (22.6) 839 (50.5) 277 (16.8) Mild 373 (20.7) 252 (14.1) 351 (21.1) 161 (9.8) Moderate 240 (13.3) 150 (8.4) 442 (26.6) 114 (6.9) Severe 2 (0.1) 3 (0.2) 46 (2.8) 2 (0.1) Revised: 25 February 2021 21 Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 74 of 104 Page ID #:74

Pfizer-BioNTech Pfizer-BioNTech COVID-19 COVID-19 Vaccine Placebo Vaccine Placebo Dose 1 Dose 1 Dose 2 Dose 2 Na=1802 Na=1792 Na=1660 Na=1646 nb (%) nb (%) nb (%) nb (%) Headachec Any 454 (25.2) 325 (18.1) 647 (39.0) 229 (13.9) Mild 348 (19.3) 242 (13.5) 422 (25.4) 165 (10.0) Moderate 104 (5.8) 80 (4.5) 216 (13.0) 60 (3.6) Severe 2 (0.1) 3 (0.2) 9 (0.5) 4 (0.2) Chillsc Any 113 (6.3) 57 (3.2) 377 (22.7) 46 (2.8) Mild 87 (4.8) 40 (2.2) 199 (12.0) 35 (2.1) Moderate 26 (1.4) 16 (0.9) 161 (9.7) 11 (0.7) Severe 0 (0.0) 1 (0.1) 17 (1.0) 0 (0.0) Vomitingd Any 9 (0.5) 9 (0.5) 11 (0.7) 5 (0.3) Mild 8 (0.4) 9 (0.5) 9 (0.5) 5 (0.3) Moderate 1 (0.1) 0 (0.0) 1 (0.1) 0 (0.0) Severe 0 (0.0) 0 (0.0) 1 (0.1) 0 (0.0) Diarrheae Any 147 (8.2) 118 (6.6) 137 (8.3) 99 (6.0) Mild 118 (6.5) 100 (5.6) 114 (6.9) 73 (4.4) Moderate 26 (1.4) 17 (0.9) 21 (1.3) 22 (1.3) Severe 3 (0.2) 1 (0.1) 2 (0.1) 4 (0.2) New or worsened muscle painc Any 251 (13.9) 149 (8.3) 477 (28.7) 87 (5.3) Mild 168 (9.3) 100 (5.6) 202 (12.2) 57 (3.5) Moderate 82 (4.6) 46 (2.6) 259 (15.6) 29 (1.8) Severe 1 (0.1) 3 (0.2) 16 (1.0) 1 (0.1) New or worsened joint painc Any 155 (8.6) 109 (6.1) 313 (18.9) 61 (3.7) Mild 101 (5.6) 68 (3.8) 161 (9.7) 35 (2.1) Moderate 52 (2.9) 40 (2.2) 145 (8.7) 25 (1.5) Severe 2 (0.1) 1 (0.1) 7 (0.4) 1 (0.1) Use of antipyretic or pain medication 358 (19.9) 213 (11.9) 625 (37.7) 161 (9.8) Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. a. N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose. b. n = Number of participants with the specified reaction. c. Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity. d. Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration. e. Mild: 2 to 3 loose stools in 24 hours; Moderate: 4 to 5 loose stools in 24 hours; Severe: 6 or more loose stools in 24 hours. * Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.

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Unsolicited Adverse Events

Serious Adverse Events

In Study 2, among participants 16 to 55 years of age who had received at least 1 dose of vaccine or placebo (Pfizer-BioNTech COVID-19 Vaccine = 10,841; placebo = 10,851), serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.3% of placebo recipients. In a similar analysis, in participants 56 years of age and older (Pfizer-BioNTech COVID-19 Vaccine = 7960, placebo = 7934), serious adverse events were reported by 0.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.6% of placebo recipients who received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. Appendicitis was reported as a serious adverse event for 12 participants, and numerically higher in the vaccine group, 8 vaccine participants and 4 placebo participants. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

Non-Serious Adverse Events

Overall in Study 2 in which 10,841 participants 16 to 55 years of age received Pfizer-BioNTech COVID-19 Vaccine and 10,851 participants received placebo, non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported in 29.3% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 13.2% of participants in the placebo group, for participants who received at least 1 dose. Overall in a similar analysis in which 7960 participants 56 years of age and older received Pfizer-BioNTech COVID-19 Vaccine, non-serious adverse events within 30 days were reported in 23.8% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 11.7% of participants in the placebo group, for participants who received at least 1 dose. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. The higher frequency of reported unsolicited non-serious adverse events among Pfizer BioNTech COVID-19 Vaccine recipients compared to placebo recipients was primarily attributed to local and systemic adverse events reported during the first 7 days following vaccination that are consistent with adverse reactions solicited among participants in the reactogenicity subset and presented in Tables 3 and 4. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy were imbalanced with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. Throughout the safety follow-up period to date, Bell’s palsy (facial paralysis) was reported by four participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of Bell’s palsy were reported in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro- inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

6.2 Post Authorization Experience

The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema) Revised: 25 February 2021 23 Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 76 of 104 Page ID #:76

8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS

See Overall Safety Summary (Section 6) for additional information.

The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for MANDATORY reporting of the listed events following Pfizer-BioNTech COVID-19 Vaccine to the Vaccine Adverse Event Reporting System (VAERS): • Vaccine administration errors whether or not associated with an adverse event • Serious adverse events* (irrespective of attribution to vaccination) • Cases of Multisystem Inflammatory Syndrome (MIS) in children and adults • Cases of COVID-19 that result in hospitalization or death

*Serious adverse events are defined as: • Death • A life-threatening adverse event • Inpatient hospitalization or prolongation of existing hospitalization • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions • A congenital anomaly/birth defect • An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above

Instructions for Reporting to VAERS

The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using one of the following methods: • Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or • If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. If you need additional help submitting a report you may call the VAERS toll-free information line at 1-800-822-7967 or send an email to [email protected].

IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please complete the entire form with detailed information. It is important that the information reported to FDA be as detailed and complete as possible. Information to include: • Patient demographics (e.g., patient name, date of birth) • Pertinent medical history • Pertinent details regarding admission and course of illness • Concomitant medications • Timing of adverse event(s) in relationship to administration of the Pfizer-BioNTech COVID-19 Vaccine • Pertinent laboratory and virology information • Outcome of the event and any additional follow-up information if it is available at the time of the VAERS report. Subsequent reporting of follow-up information should be completed if additional details become available.

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The following steps are highlighted to provide the necessary information for safety tracking: 1. In Box 17, provide information on Pfizer-BioNTech COVID-19 Vaccine and any other vaccines administered on the same day; and in Box 22, provide information on any other vaccines received within one month prior. 2. In Box 18, description of the event: a. Write “Pfizer-BioNTech COVID-19 Vaccine EUA” as the first line. b. Provide a detailed report of vaccine administration error and/or adverse event. It is important to provide detailed information regarding the patient and adverse event/medication error for ongoing safety evaluation of this unapproved vaccine. Please see information to include listed above. 3. Contact information: a. In Box 13, provide the name and contact information of the prescribing healthcare provider or institutional designee who is responsible for the report. b. In Box 14, provide the name and contact information of the best doctor/healthcare professional to contact about the adverse event. c. In Box 15, provide the address of the facility where vaccine was given (NOT the healthcare provider’s office address).

Other Reporting Instructions

Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.

To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a copy of the VAERS form to Pfizer Inc.

Website Fax number Telephone number

www.pfizersafetyreporting.com 1-866-635-8337 1-800-438-1985

10 DRUG INTERACTIONS

There are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.

11 USE IN SPECIFIC POPULATIONS

11.1 Pregnancy

Risk Summary

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

In a reproductive and developmental toxicity study, 0.06 mL of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid (mRNA) (30 mcg) and other ingredients included in a single human dose of Pfizer-BioNTech COVID-19 Vaccine was administered to female rats by the intramuscular route on four occasions: 21 and 14 days prior to mating, and on gestation days 9 and 20. No Revised: 25 February 2021 25 Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 78 of 104 Page ID #:78

vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study.

11.2 Lactation

Risk Summary

Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion.

11.3 Pediatric Use

Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine in adolescents 16 and 17 years of age is based on extrapolation of safety and effectiveness from adults 18 years of age and older. Emergency Use Authorization of Pfizer BioNTech COVID-19 Vaccine does not include use in individuals younger than 16 years of age.

11.4 Geriatric Use

Clinical studies of Pfizer-BioNTech COVID-19 Vaccine include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy [see Overall Safety Summary (6.1) and Clinical Trial Results and Supporting Data for EUA (18.1)]. Of the total number of Pfizer-BioNTech COVID-19 Vaccine recipients in Study 2 (N=20,033), 21.4% (n=4,294) were 65 years of age and older and 4.3% (n=860) were 75 years of age and older.

13 DESCRIPTION

The Pfizer-BioNTech COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. Each dose of the Pfizer-BioNTech COVID-19 Vaccine contains 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.

Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients: lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]- N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose.

The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. The vial stoppers are not made with natural rubber latex.

14 CLINICAL PHARMACOLOGY

14.1 Mechanism of Action

The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19.

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18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

18.1 Efficacy in Participants 16 Years of Age and Older

Study 2 is a multicenter, multinational, Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate–selection, and efficacy study in participants 12 years of age and older. Randomization was stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the ≥56-year stratum. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. Participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).

In the Phase 2/3 portion approximately 44,000 participants 12 years of age and older were randomized equally and received 2 doses of Pfizer-BioNTech COVID-19 Vaccine or placebo separated by 21 days. Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19.

The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age and older (18,242 in the Pfizer-BioNTech COVID-19 Vaccine group and 18,379 in the placebo group) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. Table 5 presents the specific demographic characteristics in the studied population.

Table 5: Demographics (population for the primary efficacy endpoint)a Pfizer-BioNTech COVID-19 Vaccine Placebo (N=18,242) (N=18,379) n (%) n (%) Sex Male 9318 (51.1) 9225 (50.2) Female 8924 (48.9) 9154 (49.8) Age (years) Mean (SD) 50.6 (15.70) 50.4 (15.81) Median 52.0 52.0 Min, max (12, 89) (12, 91) Age group ≥12 through 15 years 46 (0.3) 42 (0.2) ≥16 through 17 years 66 (0.4) 68 (0.4) ≥16 through 64 years 14,216 (77.9) 14,299 (77.8) ≥65 through 74 years 3176 (17.4) 3226 (17.6) ≥75 years 804 (4.4) 812 (4.4) Race White 15,110 (82.8) 15,301 (83.3) Black or African American 1617 (8.9) 1617 (8.8) American Indian or Alaska Native 118 (0.6) 106 (0.6) Asian 815 (4.5) 810 (4.4) Native Hawaiian or other Pacific Islander 48 (0.3) 29 (0.2) Otherb 534 (2.9) 516 (2.8)

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Pfizer-BioNTech COVID-19 Vaccine Placebo (N=18,242) (N=18,379) n (%) n (%) Ethnicity Hispanic or Latino 4886 (26.8) 4857 (26.4) Not Hispanic or Latino 13,253 (72.7) 13,412 (73.0) Not reported 103 (0.6) 110 (0.6) Comorbiditiesc Yes 8432 (46.2) 8450 (46.0) No 9810 (53.8) 9929 (54.0) a. All eligible randomized participants who receive all vaccination(s) as randomized within the predefined window, have no other important protocol deviations as determined by the clinician, and have no evidence of SARS-CoV-2 infection prior to 7 days after Dose 2. b. Includes multiracial and not reported. c. Number of participants who have 1 or more comorbidities that increase the risk of severe COVID-19 disease • Chronic lung disease (e.g., emphysema and chronic bronchitis, idiopathic pulmonary fibrosis, and cystic fibrosis) or moderate to severe asthma • Significant cardiac disease (e.g., heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and pulmonary hypertension) • Obesity (body mass index ≥ 30 kg/m2) • Diabetes (Type 1, Type 2 or gestational) • Liver disease • Human Immunodeficiency Virus (HIV) infection (not included in the efficacy evaluation)

Efficacy Against COVID-19

The population in the primary efficacy analysis included all participants 12 years of age and older who had been enrolled from July 27, 2020, and followed for the development of COVID-19 through November 14, 2020. Participants 18 to 55 years of age and 56 years of age and older began enrollment from July 27,2020, 16 to 17 years of age began enrollment from September 16, 2020 and 12 to 15 years of age began enrollment from October 15, 2020.

The vaccine efficacy information is presented in Table 6.

Table 6: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2, by Age Subgroup – Participants Without Evidence of Infection and Participants With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Population First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection* Pfizer-BioNTech Placebo COVID-19 Vaccine Na=18,198 Na=18,325 Cases Cases n1b n1b Vaccine Efficacy % Subgroup Surveillance Timec (n2d) Surveillance Timec (n2d) (95% CI) All subjectse 8 162 95.0 (90.3, 97.6)f 2.214 (17,411) 2.222 (17,511) 16 to 64 years 7 143 95.1 (89.6, 98.1)g 1.706 (13,549) 1.710 (13,618) 65 years and older 1 19 94.7 (66.7, 99.9)g 0.508 (3848) 0.511 (3880)

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First COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior SARS-CoV-2 infection Pfizer-BioNTech Placebo COVID-19 Vaccine Na=19,965 Na=20,172 Cases Cases n1b n1b Vaccine Efficacy % Subgroup Surveillance Timec (n2d) Surveillance Timec (n2d) (95% CI) All subjectse 9 169 94.6 (89.9, 97.3)f 2.332 (18,559) 2.345 (18,708) 16 to 64 years 8 150 94.6 (89.1, 97.7)g 1.802 (14,501) 1.814 (14,627) 65 years and older 1 19 94.7 (66.8, 99.9)g 0.530 (4044) 0.532 (4067) Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting). * Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis. a. N = number of participants in the specified group. b. n1 = Number of participants meeting the endpoint definition. c. Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period. d. n2 = Number of participants at risk for the endpoint. e. No confirmed cases were identified in participants 12 to 15 years of age. f. Credible interval for VE was calculated using a beta-binomial model with a beta (0.700102, 1) prior for θ=r(1-VE)/(1+r(1-VE)), where r is the ratio of surveillance time in the active vaccine group over that in the placebo group. g. Confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to the surveillance time.

19 HOW SUPPLIED/STORAGE AND HANDLING

Pfizer-BioNTech COVID-19 Vaccine Suspension for Intramuscular Injection, Multiple Dose Vials are supplied in a carton containing 25 multiple dose vials (NDC 59267-1000-3) or 195 multiple dose vials (NDC 59267-1000-2). After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. The information in this Full EUA Prescribing Information regarding the number of doses per vial after dilution supersedes the number of doses stated on vial labels and cartons.

During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

Do not refreeze thawed vials.

Frozen Vials Prior to Use

Cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials arrive in thermal containers with dry ice. Once received, remove the vial cartons immediately from the thermal container and preferably store in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF) until the expiry date printed on the label. Alternatively, vials may be stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. Vials stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks may be returned one time to the recommended storage condition of -80ºC to -60ºC

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(-112ºF to -76ºF). Total cumulative time the vials are stored at -25°C to -15°C (-13°F to 5°F) should be tracked and should not exceed 2 weeks.

Transportation of Frozen Vials

Thawed Vials Before Dilution

Thawed at Room Temperature For immediate use, thaw undiluted vials at room temperature [up to 25ºC (77ºF)] for 30 minutes. Thawed vials can be handled in room light conditions.

Vials must reach room temperature before dilution.

Undiluted vials may be stored at room temperature for no more than 2 hours.

Transportation of Thawed Vials

Vials After Dilution

After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within 6 hours from the time of dilution. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Any vaccine remaining in vials must be discarded after 6 hours. Do not refreeze.

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20 PATIENT COUNSELING INFORMATION

Advise the recipient or caregiver to read the Fact Sheet for Recipients and Caregivers.

The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system. Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html.

21 CONTACT INFORMATION

For general questions, visit the website or call the telephone number provided below.

Website Telephone number www.cvdvaccine.com

1-877-829-2619 (1-877-VAX-CO19)

This Full EUA Prescribing Information may have been updated. For the most recent Full EUA Prescribing Information, please see www.cvdvaccine.com.

Manufactured by Pfizer Inc., New York, NY 10017

Manufactured for BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz, Germany

LAB-1457-5.4

Revised: 25 February 2021

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EXHIBIT “E”

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FACT SHEET FOR RECIPIENTS AND CAREGIVERS EMERGENCY USE AUTHORIZATION (EUA) OF THE MODERNA COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) IN INDIVIDUALS 18 YEARS OF AGE AND OLDER

You are being offered the Moderna COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. This Fact Sheet contains information to help you understand the risks and benefits of the Moderna COVID-19 Vaccine, which you may receive because there is currently a pandemic of COVID-19.

The Moderna COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19.

Read this Fact Sheet for information about the Moderna COVID-19 Vaccine. Talk to the vaccination provider if you have questions. It is your choice to receive the Moderna COVID-19 Vaccine.

The Moderna COVID-19 Vaccine is administered as a 2-dose series, 1 month apart, into the muscle.

The Moderna COVID-19 Vaccine may not protect everyone.

This Fact Sheet may have been updated. For the most recent Fact Sheet, please visit www.modernatx.com/covid19vaccine-eua.

WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE

WHAT IS COVID-19? COVID-19 is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs. People with COVID- 19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

WHAT IS THE MODERNA COVID-19 VACCINE? The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.

The FDA has authorized the emergency use of the Moderna COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older under an Emergency Use Authorization (EUA).

For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this Fact Sheet.

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WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE MODERNA COVID-19 VACCINE? Tell your vaccination provider about all of your medical conditions, including if you: • have any allergies • have a fever • have a bleeding disorder or are on a blood thinner • are immunocompromised or are on a medicine that affects your immune system • are pregnant or plan to become pregnant • are breastfeeding • have received another COVID-19 vaccine

WHO SHOULD GET THE MODERNA COVID-19 VACCINE? FDA has authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age and older.

WHO SHOULD NOT GET THE MODERNA COVID-19 VACCINE? You should not get the Moderna COVID-19 Vaccine if you: • had a severe allergic reaction after a previous dose of this vaccine • had a severe allergic reaction to any ingredient of this vaccine

WHAT ARE THE INGREDIENTS IN THE MODERNA COVID-19 VACCINE? The Moderna COVID-19 Vaccine contains the following ingredients: messenger ribonucleic acid (mRNA), lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose.

HOW IS THE MODERNA COVID-19 VACCINE GIVEN? The Moderna COVID-19 Vaccine will be given to you as an injection into the muscle.

The Moderna COVID-19 Vaccine vaccination series is 2 doses given 1 month apart.

If you receive one dose of the Moderna COVID-19 Vaccine, you should receive a second dose of the same vaccine 1 month later to complete the vaccination series.

HAS THE MODERNA COVID-19 VACCINE BEEN USED BEFORE? The Moderna COVID-19 Vaccine is an unapproved vaccine. In clinical trials, approximately 15,400 individuals 18 years of age and older have received at least 1 dose of the Moderna COVID-19 Vaccine.

WHAT ARE THE BENEFITS OF THE MODERNA COVID-19 VACCINE? In an ongoing clinical trial, the Moderna COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 1 month apart. The duration of protection against COVID-19 is currently unknown.

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WHAT ARE THE RISKS OF THE MODERNA COVID-19 VACCINE? Side effects that have been reported with the Moderna COVID-19 Vaccine include: • Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness • General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and fever

There is a remote chance that the Moderna COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Moderna COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include: • Difficulty breathing • Swelling of your face and throat • A fast heartbeat • A bad rash all over your body • Dizziness and weakness

These may not be all the possible side effects of the Moderna COVID-19 Vaccine. Serious and unexpected side effects may occur. The Moderna COVID-19 Vaccine is still being studied in clinical trials.

WHAT SHOULD I DO ABOUT SIDE EFFECTS? If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Moderna COVID-19 Vaccine EUA” in the first line of box #18 of the report form.

In addition, you can report side effects to ModernaTX, Inc. at 1-866-MODERNA (1-866-663- 3762).

You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe.

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WHAT IF I DECIDE NOT TO GET THE MODERNA COVID-19 VACCINE? It is your choice to receive or not receive the Moderna COVID-19 Vaccine. Should you decide not to receive it, it will not change your standard medical care.

ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES MODERNA COVID-19 VACCINE? Currently, there is no FDA-approved alternative vaccine available for prevention of COVID-19. Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization.

CAN I RECEIVE THE MODERNA COVID-19 VACCINE WITH OTHER VACCINES? There is no information on the use of the Moderna COVID-19 Vaccine with other vaccines.

WHAT IF I AM PREGNANT OR BREASTFEEDING? If you are pregnant or breastfeeding, discuss your options with your healthcare provider.

WILL THE MODERNA COVID-19 VACCINE GIVE ME COVID-19? No. The Moderna COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.

KEEP YOUR VACCINATION CARD When you receive your first dose, you will get a vaccination card to show you when to return for your second dose of the Moderna COVID-19 Vaccine. Remember to bring your card when you return.

ADDITIONAL INFORMATION If you have questions, visit the website or call the telephone number provided below.

To access the most recent Fact Sheets, please scan the QR code provided below.

Moderna COVID-19 Vaccine website Telephone number www.modernatx.com/covid19vaccine-eua 1-866-MODERNA (1-866-663-3762)

HOW CAN I LEARN MORE? • Ask the vaccination provider • Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html • Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal- regulatory-and-policy-framework/emergency-use-authorization • Contact your state or local public health department

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WHERE WILL MY VACCINATION INFORMATION BE RECORDED? The vaccination provider may include your vaccination information in your state/local jurisdiction’s Immunization Information System (IIS) or other designated system. This will ensure that you receive the same vaccine when you return for the second dose. For more information about IISs, visit: https://www.cdc.gov/vaccines/programs/iis/about.html.

WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM? The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. To learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427.

WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)? The United States FDA has made the Moderna COVID-19 Vaccine available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.

The Moderna COVID-19 Vaccine has not undergone the same type of review as an FDA- approved or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used during the COVID-19 pandemic.

The EUA for the Moderna COVID-19 Vaccine is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).

Revised: 12/2020 5 Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 90 of 104 Page ID #:90

EXHIBIT “F”

Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 91 of 104 Page ID #:91

INTEROFFICE CORRESPONDENCE Los Angeles Unified School District Human Resources Division

TO: Local District Superintendents DATE: March 4, 2021 Executive Cabinet Administrators of Operations

FROM: Linda Del Cueto Chief Human Resources Officer

SUBJECT: HUMAN RESOURCES COVID-19 EMPLOYEE VACCINATION INFORMATION AND RESOURCES

The Moderna vaccine is currently being administered by Los Angeles Unified nurses and other licensed healthcare professionals to Los Angeles Unified employees at the following sites and will expand to additional sites moving forward: • Hollywood Park (So-Fi Stadium) • Diego Rivera Learning Complex • Edward R. Roybal Learning Center • Panorama High School

Email notifications have been sent to eligible school employees to schedule an appointment. The invitations are non-transferrable and include Vaccination Guidance for Employees (Attachment 1) as part of the email. The Principal/Supervisor Companion Document (Attachment 2) has also been shared with principals and supervisors and provides information for supervisors.

District employees may either participate in the District’s COVID-19 vaccination program or provide vaccination documentation in the form of an official Vaccination Record certified by a medical professional.

VACCINATION INTERVAL Los Angeles Unified is currently offering the Moderna vaccine which has a vaccine interval of 28 days between the 1st and 2nd (final) dose.

EMPLOYEE VACCINATION PROCEDURES All employees are eligible to receive the COVID-19 vaccination doses and will be notified to make an appointment through the District’s vaccination program when it is their turn to get vaccinated. Employees who do not participate in the District vaccination program may submit proof of vaccination from an external medical provider through the LAUSD Daily Pass found at http://DailyPass.lausd.net.

Employees are allowed to be vaccinated during their regularly scheduled workday whether an appointment is scheduled through the District or an external medical provider. Up to three hours of worktime are allotted per dose, including observation reaction time which is approximately 15-30 minutes.

Employees are to complete and submit a Certification/Request of Absence for Non-Illness (Form No. 60.NON-ILL; Reissued 9/14/2020). Under Reason for Absence, select Option “M” for Other Absences and identify MSND (Miscellaneous Natural Disaster) with explanation as COVID-19

Page 1 of 5 Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 92 of 104 Page ID #:92 vaccination. An absence due to natural disaster does not get deducted from the employees’ illness balance.

Employees are to notify their supervisor one day ahead if they are scheduling an appointment during their workday in order to assist their supervisor in making arrangements for work coverage.

Classroom teachers who schedule an appointment during their workday will request a substitute teacher for the three-hour window via the SmartFind Express system and indicate “vaccination” as the qualifying reason.

Employees who experience adverse physical reactions to the vaccination may be allotted additional time (up to three days per vaccination) with the approval of their supervisor as specified in Reference Guide REF-041184.0 and are to complete and submit a Certification/Request of Absence for Non- Illness as stated above.

Employees experiencing any reaction to the vaccine prohibiting them from returning to work for more than three days will coordinate with their supervisor to determine if there is work that can be done remotely. If remote work cannot be performed, employees may avail themselves of benefited time.

Employees who drive their personal vehicles to Hollywood Park (SoFi Stadium) or to a District location for vaccination during their workday will be reimbursed in accordance with Board and District mileage rules.

SUPERVISOR RESPONSIBILITIES Supervisors shall allow employees to be vaccinated during their regularly scheduled workday. Up to three hours of worktime (per dose) are allotted, including observation reaction time which is approximately 15-30 minutes.

SUBMISSION OF DOCUMENTATION Current District employees will submit documentation of COVID-19 vaccination through the Daily Pass web portal at http://DailyPass.lausd.net as indicated in their vaccination notification. New employees may submit results as part of their applicant processing.

New employees should submit results via:

U.S. or School Mail: Los Angeles Unified School District Human Resources Division Employee Health Services – SB 792 333 S. Beaudry Avenue, 14-110 Los Angeles, CA 90017 Fax: (213) 241-8918

For additional questions, please contact or refer to the following: • Medical: Dr. Smita Malhotra, District Medical Director, at [email protected]. • Integrated Disability Management: Dawn Watkins, Director, at [email protected]. • COVID-19 Vaccination: Eugene Hernandez, Executive Director, Response Team at [email protected]. • Staff Relations Issues: Contact the Staff Relations Field Director/Senior HR Representative assigned to your Local District/Division or email [email protected] • COVID-19 Vaccination Information and Resources: See Attachment 3 Page 2 of 5 Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 93 of 104 Page ID #:93

ATTACHMENT 1

You received an email notification that you are eligible to schedule a COVID-19 vaccine appointment. Your invitation is non-transferrable. Below is additional guidance to support you as you schedule your COVID-19 vaccination appointment.

VACCINATION GUIDANCE FOR EMPLOYEES

COVID-19 Vaccination Appointments • The Moderna vaccine will be administered by Los Angeles Unified nurses and other licensed healthcare professionals to Los Angeles Unified employees. • Current vaccinations are only available for employees scheduled for their first dose. • You will schedule your appointment at https://covidvaccine.lausd.net and will receive a confirmation email with a QR code which you must show at the time of check-in. • You must bring official identification or school ID to your appointment. Coverage and Notification • You will be allowed a three-hour window for your vaccination during your workday, including travel time to the vaccination location, and your time will be coded as Miscellaneous Natural Disaster (MSND). • Notify your supervisor at least one day ahead of your vaccination appointment. • Classroom teachers who schedule an appointment during their workday will request a substitute teacher for the three-hour window via the SmartFind Express system and indicate “vaccination” as the qualifying reason. Vaccination Verification • You will provide proof of vaccination via the DailyPass for time reporting purposes. Vaccination Location Sites Hollywood Park (SoFi Stadium) Edward R. Roybal Learning Center Gym 1000 S. Prairie Avenue 1200 Colton Street Inglewood, CA 90305 Los Angeles, CA 90026

SoFi Stadium – Google Maps Edward R. Roybal LC - Google Maps

Diego Rivera Learning Complex Panorama High School 6100 S. Central Avenue 8015 S. Van Nuys Blvd. Los Angeles, CA 90001 Panorama City, CA 91402

Rivera Learning Complex – Google Maps Panorama High School – Google Maps

For additional information on COVID-19, including FAQs, please call Los Angeles Unified’s COVID-19 Testing and Vaccination Helpdesk at (213) 241-2700.

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ATTACHMENT 2

VACCINATION GUIDANCE FOR SUPERVISORS Principal/Supervisor Companion Document

Information for Principals and Supervisors • The Moderna vaccine will be administered by Los Angeles Unified nurses and other licensed healthcare professionals to Los Angeles Unified employees. • An email notification will be sent to eligible school employees to schedule an appointment. The invitation is non-transferrable. • Employees will schedule their appointment at https://covidvaccine.lausd.net and will receive a confirmation email with a QR code which they must show at the time of check-in. Substitute Coverage and Notification Requirements • Employees will be allowed a three-hour window to receive their vaccination during their workday, including travel time, and their time will be coded as Miscellaneous Natural Disaster (MSND). • Employees will notify their supervisor at least one day in advance of their vaccination appointment. • Classroom teachers will request a substitute teacher for the three-hour window via the SmartFind Express system and indicate “vaccination” as the qualifying reason. • Funding will be provided by the District and time reporters will receive instructions and funding source information for substitute teacher coverage. • Substitute teachers are requested for three hours but may be held over in the event of unforeseen circumstances. Vaccination Verification • Employees will provide proof of vaccination via the DailyPass for time reporting purposes. Vaccination Location Sites Hollywood Parks (SoFi Stadium) Edward R. Roybal Learning Center Gym 1000 S. Prairie Avenue 1200 Colton Street Inglewood, CA 90305 Los Angeles, CA 90026

SoFi Stadium – Google Maps Edward R. Roybal LC - Google Maps

Diego Rivera Learning Complex Panorama High School 6100 S. Central Avenue 8015 S. Van Nuys Blvd Los Angeles, CA 90001 Panorama City, CA 91402

Rivera Learning Complex – Google Maps Panorama High School – Google Maps

For information regarding the above guidance, please contact your Staff Relations Field Director and/or Senior HR Representative.

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ATTACHMENT 3

COVID-19 VACCINATION INFORMATION AND RESOURCES Listed below are educational resources about the COVID-19 vaccine and the vaccination process from health partners and health authorities.

Los Angeles Unified Medical Director of Employee Health Services Dr. Smita Malhotra shares information about the COVID-19 vaccine: • https://lausd.wistia.com/medias/zy37jhyrh2 • The video will be also be available through MyPLN (keyword: vaccineinfo2021)

Los Angeles County Department of Public Health Contains general information about the COVID-19 vaccine and educational materials • LA County COVID-19 Vaccine - LA County Department of Public Health • FAQ: http://www.ph.lacounty.gov/media/Coronavirus/docs/about/FAQ-Vaccine.pdf • Vaccine Misinformation: http://www.ph.lacounty.gov/media/Coronavirus/docs/about/COVID19VaccineMisinformation. pdf

Centers for Disease Control and Prevention (CDC) Contains resources and informational materials about the COVID-19 vaccine • https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html

University of California Los Angeles (UCLA) UCLA has created a multilingual resource hub with a number of videos and information in various languages • https://www.translatecovid.org/

Johns Hopkins University The Johns Hopkins Bloomberg School of Public Health has created an informational video on the COVID-19 vaccine and how mRNA vaccines work • https://www.youtube.com/watch?v=w4sUuFBEo2g

Cincinnati Children's Hospital Contains videos and resources for families • https://www.cincinnatichildrens.org/patients/coronavirus-information/vaccines • https://www.cincinnatichildrens.org/patients/coronavirus-information/vaccines/busting-myths

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EXHIBIT “G”

Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 97 of 104 Page ID #:97

Dear Members:

Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 98 of 104 Page ID #:98

As previously reported, Adriana Salazar Avila and Mike Ford met with District representatives on Friday, January 29th, to discuss the District’s planned implementation of COVID-19 vaccinations for District employees and its draft Reference Guide on this topic.

Although it appears the law is on the District’s side regarding mandatory vaccinations, we are urging the District to make COVID vaccines voluntary for District employees. It is important to note that a start date has not been set for the vaccination of District employees. As you’re probably aware, Superintendent Beutner continues to wrangle with State and County officials to secure vaccinations for District employees. He has asked for 25,000 vaccinations for District employees.

We wanted to share some of the Q&A from our meeting with the District, hoping that it answers some of your pending questions.

PLEASE NOTE THAT THIS IS INFORMATION WE HAVE TO DATE. WITH THE EVERCHANGING LANDSCAPE SURROUNDING COVID-19 VACCINATIONS AND STATE/COUNTY/DISTRICT DIRECTIVES AND POLICIES, THE ANSWERS BELOW MAY VERY WELL CHANGE.

1. Will all District employees be required to be vaccinated? Are any exceptions being made for teachers? If so, what are the exceptions and provide a copy of any relevant documents reflecting agreements reached with UTLA regarding this. Answer: All District employees will be required to be vaccinated. No exceptions have been made and no agreements have been reached with any other bargaining units. Available exemptions will be made for all employees regardless of their bargaining unit or lack thereof (non-represented employees). 2. Which vaccine will be used? Answer: The District will acquire the Moderna vaccine. 3. When will our members receive educational information about the vaccine and vaccination process? Answer: The District is working on preparing educational materials. 4. If our members have an adverse reaction to the mandatory vaccine, why should they have to use their personal benefit time? Answer: The District believes that Workers Comp Leave is the most appropriate benefit time to be used for adverse reactions. 5. Will the District indemnify members in case of severe adverse reactions? Answer: The District will rely on their Workers Comp insurance. 6. What is the reasonable accommodation process that will be followed? Please provide details. Answer: These details are not yet Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 99 of 104 Page ID #:99

available because of the expected widespread nature of reasonable accommodations that will have to be made. 7. How will the District address the large contingent of African American employees who have serious concerns about people of color being used as experimental subjects for vaccines in the past? Their objections may not be religious in nature, but their objections, based on documented history, cannot be ignored. Answer: The District is working with faith-based groups to address these concerns. 8. The State and County have a shortage of vaccines available. Under these circumstances, what happens when employees are unable to be vaccinated by the deadline(s) established by the District? Answer: There are currently no deadlines in place because of this reason. 9. When is the date by which employees must be vaccinated? Answer: A deadline has not been established.

EXEMPTIONS

As you might expect, we spent a significant amount of time discussing exemptions to vaccinations. The District is required to offer legal exemptions and undergo a reasonable accommodation process for employees upon request. THIS DOES NOT MEAN THAT EMPLOYEES CAN SIMPLY ASK TO BE “EXEMPT” FROM BEING VACCINATED. Instead, this means that an employee who requests an exemption will have to state a basis for the exemption and go through the reasonable accommodation process and demonstrate that they will not “pose a direct threat at the worksite”. This means you will have to demonstrate how your work can be performed from home, a remote location, or at a time when you do not pose a direct threat.

If the District is unable to accommodate you without an undue burden to the District, you may be barred from the worksite. This means you will not be working if your work can ONLY be performed at the worksite, and you are not allowed to enter.

WHAT’S HAPPENING NOW?

Currently, approximately 700 LAUSD employees have been asked to be vaccinated for COIVD-19. The employees have been classified by LAUSD as healthcare workers because they work at or provide a specific service to the current COVID-19 testing sites.

The District is aware of the shortage of vaccines and this is impacting its ability to roll out their mandatory vaccination program for current and future employees.

Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 100 of 104 Page ID #:100

We pointedly asked the District why they are rushing to have employees vaccinated. Their answer was so that we can get back to normal as quickly as possible. We asked the District why they didn’t first offer vaccinations to those employees who want to be vaccinated, making it voluntary. They responded by noting that they want all employees vaccinated because a single person who is unvaccinated can pose a threat to everyone at their worksite.

We asked about those employees who are not currently classified as healthcare workers or who may be working from home that want to be vaccinated now; can they skip ahead of those who are already being asked to vaccinate and have not? The District’s reply was that they are being closely monitored by LA County and it is the County who allows them to move from one Phase or Tier to the next, not the availably or willingness of employees.

The biggest hurdle the District faces in getting vaccines for its employees is that the guidelines for vaccinations are constantly changing, and there is a limited supply of vaccinations available.

We are nowhere near done discussing this issue and plan to schedule more meetings with the District as more information becomes available.

If you are one of the 700 who have been classified as healthcare workers, we are aware that St. John’s Medical Center is available for appointments or walk- ins. Kaiser Permanente is also offering vaccines for healthcare workers and anyone over the age of 75. You do not have to have Kaiser insurance to be vaccinated at Kaiser. To be vaccinated anywhere, you must have a photo ID, proof of eligibility (to be vaccinated) and present your medical insurance card.

DPA TIME CALENDAR

We are aware there was a lag in the ability of timekeepers to enter the pay differential. Last night a 2021 Differential Payroll calendar was sent to all timekeepers which will also be posted on the Payroll website at https://achieve.lausd.net/Page/16980.

RETURN FROM SAFER AT HOME

The District has decided to postpone the implementation of its Safer at Home Order, acknowledging that its planned implementation was premature. We will provide an update once we have had an opportunity to meet with the District and all affected Labor Partners.

TO BE CLEAR, THE PROPOSED ORDER TO RE-OPEN SCHOOLS ON FEBRUARY 16TH AND/OR 22ND HAS BEEN RESCINDED. Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 101 of 104 Page ID #:101

VACCINE EDUCATION

Kaiser Permanente reached out to our Local Union to offer a COVID-19 Vaccine Webinar focused on the Education Community.

The coronavirus has had a profound impact on nearly every school and every community across the country and the world. Its effect is radically re-shaping how we envision school life. Kaiser Permanente Thriving Schools is here to support you.

We are offering a webinar series focused on supporting the comprehensive health needs of students, educators, school staff, and the entire education community, as we navigate the impact of COVID 19. Join us and get information on how to navigate this new normal.

Webinar: COVID-19 Vaccines: Focus on the Education Community

You’ll learn about:

• COVID-19 vaccines —Clinical information around development and safety of vaccines • Focus on Your Questions —Frequently asked questions related to related to public and clinical health of COVID-19 and the school community

Note: This webinar will not cover vaccine distribution for school districts and employees.

From presenters:

• Deb Friesen, MD, MBA, FACP, Physician Advisor Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 102 of 104 Page ID #:102

• Annie Reed, DrPH, MPP, National Director of Thriving Schools

Choose the time that works for you:

February 16th, 12:30 PM - 1:00 PM PST - To Register, Click Here

February 16th, 3:30 PM - 4:00 PM PST - To Register, Click Here

February 17th, 5:30 PM - 6:00 PM PST - To Register, Click Here

Additional Resources

Thriving Schools Website

Planning for the Next Normal at School Playbook

Resources for Schools and Families Impacted by COVID-19

Please note that this is NOT from LAUSD and should not be considered Vaccine Education offered by your employer.

James R. Hoffa Memorial Scholarship

For the sons, daughters, and financial dependents of Teamster members: Academic scholarships ranging from $1,000 to $10,000 for high school seniors planning to attend a four-year college or university and training/vocational program awards of up to $2,000 for use at community colleges and trade schools.

Applications can be found here: https://aim.applyISTS.net/JRHMSF

The deadline to apply is March 1, 2021. For general questions about the James R. Hoffa Memorial Scholarship Fund, please call 855-670-ISTS (4787) or Email: [email protected].

EMPLOYEE ASSISTANCE PROGRAM (EAP)

As a reminder, the District will provide Employee Assistance Program (EAP) through Anthem to all LAUSD employees, as a free resource during these unprecedented times. The program is confidential and accessible 24 hours a day, 7 days a week. It offers a wide variety of professional services, referrals, and online resources to help cope with stressful situations. Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 103 of 104 Page ID #:103

Some of the services include:

• 3 one-on-one professional counseling by phone, in-person, or online per issue • Crisis Consultation • Legal and financial consultation • ID recovery and monitoring • Dependent care and daily living resources • Online digital resources

YOU DO NOT HAVE TO BE AN ANTHEM MEMBER TO QUALIFY FOR EAP. For more information please call Anthem EAP at (800) 999-7222, or visit AnthemEAP.com and enter the code: LAUSD.

Adriana Salazar Avila and Mike Ford continue to remain available via email, text, and cell phone. Again, text messages and emails are likely to receive the fastest response, but our goal is to answer all calls, emails, and texts within 24 hours. If you have an emergency or don’t hear back from us within 48 hours, PLEASE contact us AGAIN!!! Do not wait!

In solidarity,

Adriana Salazar Avila [email protected] (310) 365-7872

Mike Ford [email protected] (310) 499-3556

Lourdes M. Garcia Rick Middleton President Secretary-Treasurer Teamsters Local 572 Teamsters Local 572

www.teamsters572.org

Case 2:21-cv-02388 Document 1 Filed 03/17/21 Page 104 of 104 Page ID #:104

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